chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Post vax, the pt developed an itchy throat and some shortness of breath; came to office and given Benadryl. On 10/12/00, the pt experienced abdominal pain, lightheadedness and shortness of breath; couldn't breathe, taken to ER. Had Benadryl in ambulance which resolved her symptoms. Same thing happened on 10/13/00 and he was started on Prednisone. On 10/14/00, he was carried into office gasping for air with angioedema and uvula swelling. Epinephrine and Benadryl given without relief. Transported to ER for admission. Never had similar problem. Being discharged today, will closely follow-up.
I was one month away from birth. I was healthy with a healthy baby to be born on. On 08/06/19 I was given the Tdap shot.  One week later I began to notice bruises up and down my legs, arms and my pregnant belly. Over the next two weeks I was experiencing daily nose bleeds which I had never had before. I would go to sleep and then wake up with these sudden bruises that were not there the night before. After the two weeks of symptoms, I told my OB who ordered a CBC. I was admitted to the hospital right away with a platelet count of 12. I was diagnosed with ITP. Doctors ruled out HELLP, pre-eclampsia, or infections. I was given two platelet transfusions and four day course of Dexamethasone because my platelet count was critically low and unsafe to have my planned c section. Those treatments were able to get me to a count of 47. The ITP continued to worsen after birth with a count of 7. I began high does Prednisone 70mg with a taper over 5 months. I had four Rituximab chemo infusions. I had to stop breastfeeding which was crushing  and overwhelmingly sad due to the Rituximab. It wasn't safe for baby. I had about nine IVIG infusions. Nothing was working. IVIG would last about two weeks. This went on for several months. I continued to bruise on my arms and legs, and have petechia. I was fatigued. The numbers continued below 20 even after all theses treatments. I then had to have a splenectomy on 01/02/20 and remove a perfectly healthy organ. I lost hair. Gained almost 40 pounds on steroids, continuing to gain weight even after the baby.
arm slightly sore/then a few days later it got very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm slightly sore/then a few days later it got very sore) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Tendinitis (biceps tendinitis) in 2018.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm slightly sore/then a few days later it got very sore). At the time of the report, VACCINATION SITE PAIN (arm slightly sore/then a few days later it got very sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment (1-10): 100 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Significant: Medical history provided
Two fever blisters have appeared within 12 hours of receiving the vaccine as well as moderate soreness at vaccination site for the first 24 hours
Chills, body aches, temp (highest was 102), migraine and nausea.
The pt developed a rash on the thighs, upper extremities, dermatitis and eczema.
Had redness, swelling and increased warmth within 2-3 hrs after shot and had difficulty moving and lifting left arm over next 2-3 days. Right arm has some redness and swelling after injection but resolved. Guardian just told us of event on 1-30-19 prior to giving booster vaccines.
Breakthrough case after Covid vaccination. Dose #1 3/31/21 Dose #2 4/29/21. C/O fever, headache, and cough. Onset 9/21/2021.
Patient received moderna vaccine on 5/18/21 and 6/18/21. COVID positive on 2/2/22 and presented to ER on 2/2/22. Admitted for a CVA. Patient was initially started on vancomycin and cefepime for septic joint which was deescalated to Keflex once it was ruled out. Patient also tested positive for COVID-19 on presentation but was asymptomatic throughout his stay. Discharged on 2/10/22
Information has been received from a mother concerning her 16 year old daughter with sulfonamide allergy who on 12-AUG-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included varicella virus vaccine live (manufacturer unknown) and Hepatitis A vaccine (inactive) (manufacturer unknown). The mother reported that her daughter fainted after receiving the first dose of GARDASIL. Blood pressure test was performed for half an hour after the experience, (results not provided). The mother also reported that her daughter currently had redness and hardness at the injection site about 4 inches big. At the time of report, the daughter had not recovered. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested.
Mom called 3PM stating pt had very large amt swelling on leg & had not stopped crying since shot given;
Pt recvd 1st dose of Hep B vax on 1AUG91 & in mid-AUG 1991, pt devel a rash;
PATIENT ARM A  LITTLE SORE WAS GIVEN 3 DOSES  1ST 9-28-20 2ND 12-20-20 DOSE GIVEN IN ERROR 5/2/22
Case previously recorded as MA2009-3828. Initial case report received from a physician, via Novartis Medical Communication, on 06 NOV 2009. A 3-year-old male patient was vaccinated with S-OIV FLUVIRIN  (batch no. 100922) i.m., an off-label indication. No adverse event was reported. MedCom reference no.: NA09-007760.
I have been having vertigo since sep 7, 2021 and prior to that it was slight. I have taken prednisone and meclizine and nothing has helped so far.
Patient complains of area of itching and redness with mild swelling (baseball-sized) with smaller interior area that is tender, more red, and firm (quarter-sized) at site where Zostavax was injected 6/21/2011.
Approximately 5-7 hours after vaccines administered, infant was sleeping, mom noticed infant grunting and color was grey . No vomiting,  no coughing, no known wheezing or aspiration, no fever.  Family called 911, once paramedics arrived (approx 20 minutes from discovery), pt was breathing well and paramedics "cleared" infant. Infant not taken to ER. Family noted similar but much more brief episode the next day as well.
Pt received second booster shot even though pt not eligible (i.e. not immunocompromised). Pfizer contacted and had no advice other than pt should not have been vaccinated. Family contacted and counselled on error. Advised to monitor pt for any abnormal sx. Family agreeable with plan. Unanticipated event report generated within facility and forwarded to management.
pt parent called to report pt w/low grade fever & vomiting x6 this AM 15APR97;
I was traveling in another country and a number of the people on the tour contracted the COVID-19 virus they left early and an older woman contracted the virus later around the end of the tour. 14OCT2022 I was feeling ill and my throat was scratchy by the time I got home which was about ten at night or so, not that I was really ill but like a cold with no fever I never had a fever so I tested when I got home for COVID-19 and I was positive. I slept in the guest room so my elderly husband would not contract the virus. I knew I was positive but did not feel real awful. I called the on call line and I was prescribed PAXLOVID but my kidney functions were not normal so I was given half dose around Christmas time or around January. I started to feel short of breath and my voice would be very hoarse or throaty and people would notice it. Around the middle of March I had my annual physical and was put on a new inhaler and the voice thing is still going on.
The afternoon of 10/10/2021 my shoulder was really sore. I thought I injured it working out. I was changing in the bathroom that evening and noticed the whole right side of my neck clavicle, pectoral and underarm of my right side was extremely swollen.  The pain was 7/10.  My throat was sore on the right hand side. I had extreme fatigue as well. I still have extreme fatigue, headaches and swelling. I alternate between tylenol and ibuprofen. I also use a heating pad. My doctor assumes its a reaction to the vaccine and told me to continue doing what I'm doing. I am still feeling my symptoms though they are subsiding slowly. I feel terrible.
Hard, hot, raised area approx. 1 cm below injection site.  Approx. 5 cm wide by 3 cm--elliptical in shape.  The erythema was very tender to light touch.
Some swelling  and redness at injection site on evening of 24th. Larger area of swelling and reddness on the 25th continuing to expand to involve the area from the injection site to the elbow on the 26th. Patient called pharmacy on the 27th to inform that the area of swelling had not increased but still involved the entire area of the arm from the injection site to the elbow. Patient verbally described the area, has not been seen by pharmacist or MD.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four-months old male patient who was vaccinated with a dose of ACT-HIB] and 0.5 ml dose of PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. On 18-Oct-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5530AA; expiry date: 04-Oct-2019 via intramuscular route in the left thigh. On an unknown date (reported as same-visit), the patient received a dose of suspect HIB (PRP/T) VACCINE lot UIN07AA via intramuscular route in the right thigh. On an unknown date (reported as same-visit), the patient received a dose of suspect DIPHTHERIA VACCINE TOXOID; HIB VACCINE CONJ (TET TOX); PERTUSSIS VACCINE ACELLULAR 1-COMPONENT; POLIO VACCINE INACT; TETANUS VACCINE TOXOID not produced by Sanofi Pasteur lot number not reported. It was a case of actual medication error due to wrong vaccine administered and extra dose administered. It was not reported whether the patient experienced any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
vaccine between 2 and 6 pm on 10/18/2022 symptoms start Wednesday morning. rash on right cheek and right side of neck. moved down center of chest. as the day went on, progressed to lower right side groin area and lower abdomen. Thursday morning little bit of rash now on left arm and leg. no tongue or lip swelling and no difficulty breathing. pharmacist recommended Benadryl up to 50 mg 4 times a day and famotidine 20mg in the evening. RPh also suggest informing MD thru System and go to ER if needed.    Called her this AM she said a little worse but Benadryl helped
Process began with moderate mild pain and tenderness in left sided occipital and posterior auricular lymph nodes. Spread to left side of face and scalp. Started as moderate tenderness to palpation and evolved over a week into mild swelling a obvious erythema over face and scalp. Began to move over to right side of face and wane over left side. The facial and forehead rash is an erythematous sunburn type appearing rash that is vascular in nature and associated with mild pruritis.
24 hours after shot, I noticed lymph swelling at my collarbone and in my armpit on the side of the injection (left side)
Progressively worsening redness, swelling, and itching over the course of the second day.
Information has been received from a physician concerning an 11 year old male who on 16-JUL-1998 was vaccinated with a first dose of MMR II HSA. On 23-APR-2001, the patient was vaccinated with a second dose of MMR II HSA. On 30-OCT-2009, the patent experienced mumps. On 01-NOV-2009, the patient was diagnosed with mumps. The patient was afebrile and had left parotitis. On 01-NOV-2009, the patient's lab results were serum IgM less than 1:10 and serum IgG was 6.12. On 07-DEC-2009, the patient's lab results were serum IgM less than 1:10, serum IgG was 7.23 and serum amylase was 40. The outcome of the mumps was not reported. No further information is available.
shortness of breath; experienced white and pink bumps on her face around her lips; experienced white and pink bumps on her face around her lips; she experienced aches and pain in her joints; blurred vision on and off; This is a spontaneous report from a non-contactable consumer (patient). A 80-years-old-female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 (79-years-old) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that patient did not have her medications, but she did state that she has had several Botox injections in the area on her face where she experienced the reaction. The 2nd day after the first dose of the vaccine (24Feb2021) she experienced white and pink bumps on her face around her lips. She also had some shortness of breath and called 911. She was admitted to the hospital. The ruled out COVID infection and Pneumonia. On the 3rd day while hospitalized she experienced aches and pain in her joints. She was discharged after 3 days. Her symptoms have subsided. She is only complaining on some blurred vision on and off. She received her first dose on 23Feb2021. Her Doctor told her she should not get the 2nd dose. Therapeutic measures were taken as a result of shortness of breath, experienced white and pink bumps on her face around her lips, she experienced aches and pain in her joints. The outcome of event she experienced aches and pain in her joints was recovering, while other events was unknown. It was reported that patient had several Botox injections in the area on her face where she experienced the reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A cluster of four patients (patient identifiers were not provided) received ADACEL (lot number UP452AA) on an unspecified date. All patients developed site warmth and redness 24 hours post vaccination. The recovery status was unknown. No further information was provided. List of Documents held by sender: none.
received dose one / on 07Sep2019 and forgot to return for dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 7th September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient forgot to return for dose two. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No further details provided on the call. Specialist forgot to ask whether pharmacist granted permission for follow up from safety.
3-4 hours after receiving vaccines, teen c/o numbness/tingling in arms and legs, feeling of uneasiness, fatigue, pain in lower - mid back 6/28/16.
received wrong dose, given dose for age 12+. Parent counseled on adverse event, no symptoms reported
Information has been received from a physician concerning a pt (age and gender not reported) with unk medical history and unk allergies who in approx Dec 2004 (winter 2004) was vaccinated IM in the arm with pneumococcal 23v polysaccharide vaccine (lot unk). Subsequently, the pt developed severe local injection site reactions in the same arm the injection was given but below the actual site of injection. It was reported that the pt recovered on an unk date. The pt sought unspecified medical attention. There was no product quality complaint involved. No additional information is not expected.
Severe headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 10:00 (Lot number: EW0217) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Other medical history: Migraine and anxiety; "Anxiety" (unspecified if ongoing), notes: Other medical history: Migraine and anxiety; "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: IMITREX. The following information was reported: HEADACHE (non-serious) with onset 18Aug2021 08:00, outcome "recovered with sequelae", described as "Severe headache". The event "severe headache" was evaluated at the physician office visit. Therapeutic measures were taken as a result of headache.  Additional Information: It is reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient had diagnosed with COVID-19. Treatment received for the adverse event with Prescription pain relief and steroids, sleep study. Since the vaccination, patient had not been tested for COVID-19. The patient had no known allergies as reported.  Follow-Up (29NOV2021): Follow-up attempts are completed. No further information is expected.
she stated woke up in the middle of the night around 11pm with the c/o a heavy chest, mom called the on call provider, and she described it as chest tightness, stuffy nose, and difficulty breathing because her throat also felt tight, Provider advised benadryl at this time, she did not have any issues talking and no other symptoms, her 02 and heart rate were good for she had a watch and could track these, he advised to be seen in office the next day 12/9/21 for a follow up, when in office she stated that the feeling never came back and she was able to sleep through the rest of the night
Rash-itching-swelling, 3-19-02, Prednisone taper 3-19-02, Atarax 25 mg three times a day.
7/21/03: went to ER with difficulty breathing (pt has history of asthma) and skin eruptions began on 7/17/03. Rash began left forehead and midchest. Also complained of sore throat on 7/22/03. 7/25/03 followed up by MD. Given inhaler at hospital.
Hives on face within 5 minutes of getting vaccine. 2 hours later hives on wrist
Patient called with complaint of soreness at site of injection from date of vaccination. States pain has continued and extended down to elbow. Worse with certain movement. Saw private physician initially about 1-15-04. Reports treated with Feldene without improvement. Saw physician again this week and began dose pak of Prednisone.
Confusion episode, hyperthyroidism and possibly tremors Keppra, methimazole Then allergic reaction (hives for 8 days and counting), removed medications, received steroid shot replaced with benadryl, Allegra, Klonopin, methylprednisone
Patient received a 1mL dose instead of a 0.5mL dose; no signs/symptoms at this time
This is the 3rd dose (booster) COVID vaccine from Pfizer. I had no obvious adverse events from the first two doses except for injection site pain. However this time, I had serious headache, neck pain and muscle ache all over the body starting from about 18 hours after dose, also had nausea and feel like vomitting. The lymph nodes on left arm where injection was given also had a little bit swollen.  The symptoms get a little bit better after 1 and a half day but the lymph nodes still swelling as of 48 hours after injection.
significant hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "significant hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the second dose, the patient had significant hair loss. The patient PC checked hormonal levels, thyroid and looked for vitamin deficiency everything came back normal. However the hair loss continued. After a few months the hair loss subsided and the patient began to regrow hair.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101863626 same drug and patient, different event and drug dose