chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via sales rep and described the occurrence of respiratory distress in a infant patient who received PEDIARIX. On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced respiratory distress (serious criteria GSK medically significant). On an unknown date, the outcome of the respiratory distress was unknown. The reporter considered the respiratory distress to be possibly related to PEDIARIX. Additional details were provided as follows: The neonatologist (name unknown) informed the reporter that two patients (babies) experienced respiratory distress after vaccination with PEDIARIX. The event occurred in the previous couple of months but specific dates were unknown. The sales representative connected the reporter with agency and agency might also report additional adverse events details. This case has been linked to case US2016GSK043333, reported by the same reporter. No further details were provided.
14MAY92 fever 101 18MAY92 fever 101, sore throat, neckk hurting, h/a behind eyes, stomachache, lethargic; mom did not want pt to have further OPV;
Pt complained of feeling dizzy and bilateral arm tingling/pain 15 minutes after receiving vaccine.  Pt was observed and periodically checked on for approximately 1 hour, she then stated that her arms and legs were itching.  I gave her 50mg of liquid diphenhydramine, over a period of 2 hours she was observed and checked on, around 5 pm she stated the itching was gone and she felt fine.  I gave her a bottle of diphenhydramine liquid and directions for use.  I followed up with the patient the following day and she said she continued to feel fine.
Throat and lip numbness.  Feeling of lump in throat and coughing.  C/o difficulty swallowing.  C/o arm swelling, redness and itching at site of injection.  Took PO Benadryl with some relief.  Seen in ED at 3 PM and treated with IV steroids.
pt recvd flu vax & devel swellling form the shoulder to the elbow w/in 2 to 3 hrs; pt also had a fever; the swelling lasted 1 wk; pt recvd an flu vax last year w/no problems;
Stable at time of vaccine 1/15/21 and 2/5/21,  Transferred to  ER  for pocketing food, Left facial drooping and left sided weakness on 7/4/21. Returned from hospital 7/14/21 w/gastrostomy nutritional status and hospice care. She expired w/end of life hospice care in place on 7/15/21.
Local reaction to shot with possible cellulitis warm to touch. TX: Keflex 200 3/4 tsp qd x 10d, Benadryl 1 tsp PO q 6 hr.
fatigue; headaches; fever; chills; soreness; Flu-like symptoms; not being able to lift arm; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, headache, fever, chills, pain, influenza-like symptoms and mobility decreased. On an unknown date, the outcome of the fatigue, headache, fever, chills, pain, influenza-like symptoms and mobility decreased were unknown.   It was unknown if the reporter considered the fatigue, headache, fever, chills, pain, influenza-like symptoms and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned Flu-like symptoms such as chills, fever soreness, fatigue also complaints of not being able to lift arm and headaches. The patient noticed that if the patient did not experience an adverse event after 1st dose they may have a mild case after 2nd dose. And if they have an adverse event after 1st dose they have a mild case after 2nd dose.  The Health care professional mentioned it was all patients well over 10 patients, so no PII was captured nor lot/exp. date.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215857:same reporter US-GLAXOSMITHKLINE-US2020214762:same reporter
Pt presented to pharmacy about 7:00pm on 6/22/21 stating he had gotten a rash on both arms and a place around  his left eye about 3 days after his second Moderna Covid shot that he received on 6/17/2021. Both arms had sparse, red spots on them.  On the side of his left eye he had it was a little red and looked a little swollen. He stated they itched some and his "itch" pills at home did not help (he could not tell me the name of them). He did state that about 3 weeks ago he had taken some steroid pills for poison ivy. He did not fill them at this pharmacy and could not tell me the name of them. He said the spots and the swelling on his eye were worse in the mornings. Told pt I would contact his primary care doctor tomorrow and he said he would as well.
sudden side effects around one hour after taking my thyroid medication. Nausea, dizziness and weakness - very winded. Pain at injection spot. Difficult to walk and just get back to bed or call someone. Blacked out in bed, waking up soon after to extreme shaking, cold, extreme pain at inject shot. Again difficult to get out of bed to find extra blankets/covering. I am not sure I feel back to sleep or just passed out but woke around 7am, extreme pain full arm, with fever 102.7, was able to get to kitchen get ice cubes. fever dropped to 101. took Tylenol once I could hold some food in stomach. Nausea, but felt like I needed to eat something. back to bed.  bed rest most of the day, when I trying to get up to eat something or pick up mail, very dizzy, light headed. Temp lingered around 101 for the next day or so. Through  weekend was very winded, but was able to contact via email doctor what was going on. Sunday temp was under 99.  other pain at injection and fategue lasted for week. Metal taste in month started Sunday 3 days after shot. Doctor not sure if I should get 2nd shot. Help. what do I do?
Severe food allergies  After the first vaccine, I began belching. My baseline was almost never burping, so to begin belching was odd. After the second vaccine, after eating, I would get a substantial amount of drainage. After a few hours, it would slow, but I would wake up with a stuff nose, which was not my baseline normal. Then finally, after I got COVID, I had a whole aray of symptoms after eating: stomach aches, liquid stools, headaches, tightening of throat and chest making it difficult to breathe( especially after ingesting sugar), feeling fatigued and lathargic, bloating, hot flashes, blurred vision and fuzzy head, body wide inflammation, and the symptoms that arose after the vaccines.
blistering, swelling of lips, itchy throat, fever occurred within 6 hours and self resolve.
DIZZY; NAUSEA; HEADACHE; FEELING HOT; COLD FINGERS; DRY LIPS; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, expiry: not reported) dose was not reported, administered on 04-APR-2021 16:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced feeling hot. On 04-APR-2021, the subject experienced cold fingers. On 04-APR-2021, the subject experienced dry lips. On 04-APR-2021 23:00, the subject experienced dizzy. On 04-APR-2021 23:00, the subject experienced nausea. On 04-APR-2021 23:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, nausea, feeling hot, cold fingers, and dizzy, and the outcome of dry lips was not reported. This report was non-serious.
pt recvd vax 17AUG93; t37.8 that evening & cont through the next day; swelling & erythema occurred upon awakening on 18AUg93; initially arm was very painful but pt was able to use arm if needed; warm to touch, induration
This case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced increased blood pressure. On an unknown date, the outcome of the increased blood pressure was recovering/resolving. It was unknown if the reporter considered the increased blood pressure to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient asked could the vaccination cause an increase in my blood pressure and reported that after vaccination her blood pressure had increased daily but  at the time of reporting it had decreased. Lab Comments: On an unknown date the patient's blood pressure was measured.
She got her vaccine, there was nothing at all initially.  At 5:00 she started feeling tired and like she started noticing her BP was increasing.  She did not want to eat anything.  She went to bed early and her BP started to rise, she started getting a pressure feeling inside and she can feel it in her whole body and her head.  Was on her side and her heart was beating against the bed.  She tried to take deep breaths and lie there.  At about 2:00 AM it stopped, the full pressure feeling went away and she was OK after that.  She has had feelings of high BP before so she knows what it is like.  She did not take anything for her reaction, was afraid to take anything.    She has left a message with her doctor, but has has not heard back from her.
rt arm hot & swollen, fingers & arm numb;skin mottled, elevated BP, itchy skin;use ice pack rx pred in dec amounts, DPh;
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 20-FEB-2017, the patient was vaccinated with improperly stored dose of M-M-R II  (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
C/O pain and tingling down left arm to fingertips day after injection. Had difficulty sleeping the night after the injection. Felt better by 8/4/13. Feels very little residual effects 8/5/13. Had slight swelling for 1 day. No treatment needed per Dr.
Patient got the shot on Saturday, Jan 2nd at around 11am. Woke up Jan 4th at 2:13am feeling the place of injection swollen, itchy and with a single hive like a bug bite, felt another on torso on the right side. Felt rapid pulse, got up to check the mirror, eyes swollen and itchy, tongue beginning to swell. Within minutes, started feeling itchy all over my body, specially mucosae, and scalp. Took 360mg of fexofenadine and 20mg famotidine, reaction started to subside. Was up monitoring until 3:45am. Still feeling itchy but significantly less at the before medication. Plan to continue with 180mg fexofenadine a day until all itchiness goes away.
pt recv vax & later in the day devel achiness @ the inj site; approx 2 wk later began to exp a tingling sensation across shoulders & down both arms; felt fatigued & fingers felt stiff; ANA titer was elevated;
The night of the vaccine (4/10/2021), and the following two days (4/11/2021, and 4/13/2021) I experienced extreme fatigue & low-grade fever (99.6F). On 4/14/2021, the injection site became red, hot, and slightly hard to the touch.
Got dark red rash as big as palm around site and up towards the armpit. Hot to the touch. Lasted 5 days and then got better. Did not see doctor.
Initial unsolicited report received from a non-health care professional (office staff) via company representative on 17 October 2015. This case involves an elderly patient (age and gender unknown) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route, dose in series and site of administration were not reported) on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date following the vaccination, the patient experienced severe health problems and severe symptoms. It was reported that patient was required to be hospitalized for treatment. Lab data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
One week post vaccination a rash appeared in the area surrounding injection site.  The rash was red and raised, with itching. The site was painful and warm to the touch.  During healing, the center has lightened, but perimeter remains red and raised. Patient reached out to PCP who was not concerned.  No intervention was suggested.  Patient reports getting lump at site of flu shot in the past,
mom states p/waking from a nap was very hot & wet; pts temp per mom was 103 R; states pt body was jerking & lasted for 2 hrs; mom states did not lose consciousness no loose bowels & eyes did not roll back; drowsiness;
Student fainted and lost consciousness for about 15 seconds at 11:00AM.  Vital signs were stable before and after the episode of syncope.  Student stated that she had not eaten anything that morning.  She told the nurse before receiving the vaccine that she had not had any reaction with the first dose of HPV vaccine.  After the syncope, she told the nurse that she had fainted with the first dose of HPV but she thought it was because she also had a large amount of blood drawn for tests at that same visit.  Student rested at the health center for a short time and then returned to her dorm room to get ready for the convocation for graduation.  She was informed about reaction symptoms and was instructed to return to the health center if she devloped any of these symptoms.  She was instructed to contact her doctor at home next week after graduation.
Information has been received from a registered nurse concerning a female patient who in approximately August 2010 "about one month ago", was vaccinated with the second dose of GARDASIL (Lot# not reported). The patient experienced immediate pain and the soreness had continued. The registered nurse reported that the vaccination was given very high on her arm and might have been into the joint. It was unknown if the patient sought medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Patient diagnosed with SIRVA (shoulder injury related to vaccine administration) post doctor visit on 11/5/21. Experienced immediate pain in arm, similar to "being socked in the arm by a fist" which radiated into the armpit and down the arm after a few days. Sleep was not comfortable either. Patient reported vaccine administration site being "higher than normal". Patient currently on a steroid taper with relief as well as planning to attend occupational therapy to correct limited range of motion.
I called Dr.  on April 12, 2021 and we had a video visit. I describe my symptoms: I thought I had a sinus infection so Dr.  referred me to the Ear Nose and Throat doctor, Dr.  . My appoint with ear nose and throat doctor was on April 15, 2021. On April 15, 2021 checked my vitals and sinuses, and determined that I had a gum infection and the next day I saw pervious Dr. , on April 16, 2021, she's a demonologist, my fingers were breaking out. Dr.  checked my figures  for a rash and said it was from my neuropathy.  Two weeks ago I had surgery on  my gums for the gum infection.
For approximately 2 weeks prior eyes felt swollen and thought I needed new glasses. July 27, I went to ER, thought because of numbness in mouth thought I was having a stroke. After CT, MRI, with and without contrast determined it was Bells Palsy.
Patient started smelling ammonia the day after receiving 2nd dose COVID-19 Pfizer and continues to smell ammonia since then.
Got COVID on 6/25 - sore throat on the 25th. Tested negative by home test until 27th. Did a PCR at pharmacy on 6/27. Came back positive on 6/28.
Information has been received from a medical assistant concerning a 59 year old female with diabetes mellitus who on 04-DEC-2006 was vaccinated with a dose of Pneumovax 23 (lot 651399/0486F).  Concomitant therapy included metformin.  On 04-DEC-2006 the patient developed redness, swelling, heat, and pain at the injection site.  The patient also experienced nausea and pain when moving her arm.  The patient sought unspecified medical attention.  At the time of this report, the outcome was unknown.  The office requested a lot check be performed on lot 651399/0486F.  The records of testing prior to release of the lot in question have been rechecked and were found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
POSSIBLE ORGAN DAMAGE; SEVERE NEUROLOGICAL ISSUES; WEIGHT GAIN; This spontaneous report received from a consumer via a company representative concerned a 29 year old male. 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 patient experienced possible organ damage, severe neurological issues, and weight gain. Laboratory data (dates unspecified) included: Weight (NR: not provided) Weight gain. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe neurological issues, and the outcome of weight gain and possible organ damage was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Within 2 hours after vaccination, developed pain behind her right ear.  Felt as if there was fluid and affected her hearing.  She took Tylenol at that time.  Around 2 a.m. the following morning (4/15), she rolled over in bed and felt a sharp pain on the left side of her neck.  She got up and looked in the mirror and saw that the area was swollen and continued to get larger as the morning went on.  She didn't take any medication this a.m.  Took her child to school and then came for evaluation.
(Rt arm) Rt upper arm with mild induration with papular spots with scals formation in an area 2 inches diameter
Note    Patient called and said that she received a flu and pneumonia shot about 3.5 weeks ago. She said that arm that she got the pneumonia shot in is feeling fine but the one she got the flu shot in, is really sore. She said that she can barely even use that arm. She's been alternating heat and ice to relieve the pain, she's been taking ibuprofen and the pain isn't letting up. She said she gets a flu shot every year and she's never reacted to it like this. She's wanting to know if you have any other suggestions?
I had the shot on Feb 4 with absolutely no reaction. No sore arm or other side effects. This morning, Feb 12, I woke up to a red itchy bump at the injection site. It?s not bad enough to get treatment so I?m going to just see how it does over the next week.
I received my first dose of the COVID 19 vaccine on the 2nd of May. Approximately a week or two later I started developing 2 unique symptoms not experienced before. First, I started getting a burning sensation across my left chest that would come and go. Second,  I started to develop pain every time I bent my thumb or pressed in the area of the metacarpal joint on my right hand. This persisted, and the week of May the 26th the burning sensation in my chest was getting stronger and the event lasting longer. It has now been a few weeks, and the symptoms were getting worse. It was enough concern to call my sister who is a nurse whom recommended I go to an urgent care. On the 26th of May I went to an urgent care. They stated that I should go to the hospital as they do not have the equipment to properly diagnose. I went to Hospital ER at approximately 4PM. It was there that I did blood work, got an EKG upon arriving and upon leaving, and x-rays of the heart. The outcome was that the physical exam, blood work, x-rays, and EKG did not show anything of major concern. The ER doctor thinks it is somehow related to the heart muscle surrounding the heart. I received baby aspirin, menthol patch, and was told to take ibuprofen as needed. For my thumb issue, I visited my chiropractor on 16 June 2021 and asked about the joint issues in the thumb, and he recommended to see my family doctor. He thinks it might be arthritis related. I am working to schedule an appointment.
10/25/21- began to experience double vision and vertigo. MRI results in demyelination in optical nerve. given steroids to improve vertigo. as of 11/9/21 still have double vision   follow up with neurologist 11/18/21
Missed miscarriage at 5 weeks gestation, I?m unsure if vaccine related it just happened around the same time. Due date was calculated Nov 3rd.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-FEB-2015 the patient was vaccinated with a dose of PROQUAD (Merck) (dose/frequency: 0.5 ml) subcutaneously that underwent temperature excursion. No adverse effect was reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). Additional information has been requested.
my lips and hands became blue with SOB and then  I started to cry uncontrollably.  It last approximately 2 hours, but I did not  go to the hospital. I am nurse, I knew  it is busy at hospital. So  I started to pray and symptoms went away.
This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 83-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on unknown date). On 11th March 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced dizziness, injection site pain, diarrhea, fever, tremor, difficulty sleeping and erythema of extremities. On an unknown date, the outcome of the dizziness, injection site pain, diarrhea, fever, tremor, difficulty sleeping and erythema of extremities were not recovered/not resolved. It was unknown if the reporter considered the dizziness, injection site pain, diarrhea, fever, tremor, difficulty sleeping and erythema of extremities to be related to SHINGRIX. Additional case details were provided as follows: The reporter stated that, the patient received 2nd dose of SHINGRIX vaccine in left arm and experienced. She experienced dizziness, pain at injection site, diarrhea, fever, shakiness all over the body, trouble sleeping and her right arm has turned red around the same area as the injection site on her left arm. The patient still experiencing the symptoms, and patient has a physician visit scheduled on the day of reporting. The reporter has been given consent for follow up. This case has been linked to US2019047142, reported by same reporter for his wife.