chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness; soreness; itchiness; warmth; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included prednisone.   On 7th May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 7th May 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site itching and injection site warmth. The patient was treated with hydrocortisone (Hydrocortisone Cream). On an unknown date, the outcome of the injection site erythema, injection site pain, injection site itching and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site itching and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm and later that day developed a palm sized red, itchy, sore, warm injection site on her left arm that persists.  The patient had treated it with hydrocortisone cream with some relief.  The patient had consented to follow up. The patient consented to healthcare professional follow up but did not know pharmacist's name. The patient did not have vaccine information for this adverse event.
Body aches and chills at first. On Sunday 3/21, my fever spiked to 103.7. called doctors office. Was told to take Tylenol for fever and if it didn't drop to the walk in or ER.  It finally dropped later that evening.  Then the next day 3/22 i have a rash on my arm i received the vaccine in.  On 3/24 it was worst. put a call back into the doctors.  Said if it continues to get worst to go to the ER. I put ice and cortisone cream on it which helped take the itching away.
pt c/o dizziness 5 min after shot.  Walked over to nurses area and had the patient lay down.  Offered patient Benadryl and she requested 100 mg.  50 mg given PO at that time.  After 10 minutes, patient complained of tightness in her throat.  Breath sounds diminished in upper lobes, audible in lower lobes. Then she complained that she could not breathe. Epi .3mg given at 1545 using Epi pen.  911 was called at this point.  Patient felt better and breathing and breath sounds improved.  She was talkative and alert and oriented.  After 5 minutes, she began struggling to breathe again and her breath sounds were stridorous.  Epi repeated at .3 mg my epi pen.  Immediate improvement in her breathing and breath sounds resulted.   EMS arrived at 1558, loaded her on the stretched and left without further incident.  She was transported to the hospital with her husband at bedside.
headache; does not feel well; transient global amnesia.; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection, Lot Number was not reported), dose 2nd via an unspecified route of administration on 18Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Feb2021 for covid-19 immunisation. Patient was diagnosed with transient global amnesia. Asked if there were reports on patient who also has gotten this side effect, after receiving her second dose she experienced a severe adverse event and was hospitalized. She was released from the hospital on 12Apr2021. She had a reaction for the first dose. With the second dose she just had the headache. She just came out of the hospital and would like to know if that was because of the vaccine. She does not feel well. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Headache      for the past few months since getting his covid vaccine     Patient presents with complaints of a headache that is on the right side of his head above his right ear. It goes on and off and lasts for a few seconds. He describes it as sharp. No radiation of pain. He is also complaining of other areas of body aches. No trauma or injury. Symptoms have been going on for the past few weeks after getting his first COVID-19 shot. It got worse after his second COVID-19 shot. He has not followed up for this. No other acute issues, symptoms, complaints.         Review of Systems  Constitutional: Negative for chills and fever.  HENT: Negative for congestion, ear discharge, ear pain and sore throat.   Eyes: Negative for discharge and redness.  Respiratory: Negative for cough, shortness of breath and wheezing.   Cardiovascular: Negative for leg swelling.  Gastrointestinal: Negative for abdominal pain, blood in stool, constipation, diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria and frequency.  Musculoskeletal: Positive for arthralgias and myalgias. Negative for back pain and neck pain.  Skin: Negative for rash.  Allergic/Immunologic: Negative for environmental allergies.  Neurological: Positive for headaches. Negative for seizures.  Hematological: Does not bruise/bleed easily.  All other systems reviewed and are negative.
Pain and swelling at injection site that did not subside, nausea and dizziness developed later that night, then had an outbreak of shingles 2 weeks following the vaccine
8 hours after getting the vaccine i started having aggressive body aches, chills and body literally shaking out of control like I was possessed and 102 fever. The pain and stiffness moved around my body starting at my shoulders and back then my hips. I finally broke the fever after 4 hours of shaking and aching. I woke up this morning with no fever but feel tired and achy with a headache front to back.
gross hematura for 6 days starting on 2/26- painless told platelets 57K, no others s/s of bleeding or bruising self limited after 6 days to GU, renal sono nomal, scheduled for cystoscopy in May repeat cbc hct 40, plts 160K dx covid in January 2021 vaccine dose #1 on 1/5/21
Tremor; significant vertigo; numbness in her thumb and first finger; Headache; elevated lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received third dose (booster) of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: 301308A and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 01Oct2021 (age at vaccination: 48 years), as dose 3 (booster), single dose for COVID-19 immunization. The patient's medical history included head injury, anxiety, and long QT syndrome. The patient's family medical history relevant to adverse events included heart disease, stroke, and breast cancer. Concomitant medications included metoprolol for heart and her mitral valve, acetylsalicylic acid (aspirin (E.C.) for long QT syndrome and blood clots in her left leg, citalopram for anxiety, and influenza vaccine inact SAG 4V (FLUCELVAX QUADRIVALENT). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3249 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 20Jan2021 (age at vaccination: 48 years), as dose 1, single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9269 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 10Feb2021 (age at vaccination: 48 years), as dose 2, single dose for COVID-19 immunization. She reacted big on the first dose and had really bad headaches and was in bed for the first 48 hours. It was not as bad with the second dose. On 01Oct2021, the patient reported that she immediately had numbness in her thumb and first finger upon injection. She said that later on, about 4 weeks later, she had a tremor on 24Oct2021. She said that she also had the usual headache and things like that on an unspecified date in Oct2021. She had significant vertigo on 17Oct2021. The doctor said that the vertigo was not related to the vaccine. She said that she had elevated lymph nodes about 2 weeks after the injection that were throughout the left arm pit, occipital area, and behind her ear on an unspecified date in Oct2021. She did not know if that contributed to the vertigo. Vertigo occurred the week of 17Oct201 and was most pronounced in the morning and stated that she still has a little bit of it. She has always been sensitive to medicine. She took a very small dose of her medications. Her symptoms after receiving her booster dose mimicked her head injury and she felt like she had a head injury all over again. The events did not required a visit to emergency room and physician office. Outcome of the event tremor was recovered on 27Oct2021, and for all other events, it was unknown.
Severe pain in arms, hands, legs and abdomen. Pain is numbness and tingling in nature. Pain is worse in right arm and leg. Very tired and unable to do much. Bedridden state for most of last 19 days. Breathing is deeper and heavier than normal. Occasional dizziness, Headache and nausea.
Information has been received from an office manager concerning a 52 year old female patient who on 10-DEC-2008 was vaccinated with PNEUMOVAX (lot #661529/0868X) intramuscularly. Subsequently the patient experienced cellulitis at the site of administration.  Patient called the practice.  Subsequently, the patient was placed on therapy with antibiotics and recovered.  The practice would like to know if there have been any other of cellulitis concerned with this lot of PNEUMOVAX.  This is one of several reports received from the same source.  A standard lot check investigation was performed.  All in-process quality checks for the lot number 661529/0868X were satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Within 5 hours post vax pt began to feel nauseated and had a fever of 99F. Pt was treated with Tylenol. An hour later her temperature increased to 102.8F and within 15 minutes had increased to 103.4. The physician treated the pt with Motrin, Tylenol and a lukewarm bath. The pt began shivering and shaking severely. At midnight her temperature was 103F. She was given more Tylenol while also continuing to be sponged down. One hour later her temperature was down to 101F. The next morning it was down to 99F. The next night at midnight she developed a severe headache and was treated with Tylenol. An hour later she was soaked. Lab work, blood work and CBC were all negative.
Child had varicella vaccine 8/7/95, became ill with rash, severe itching. Took 5 days to completely break out. No scars or pitting. Brother had 2 spots had vaccine 1/20/98 - elsewhere. Younger sister didn't get sick - had vaccine 3/5/01  at Co Hlth Dept. Pt was ill 12/10-14th/01. Several children in the area had varicella.
No adverse reaction. We were notified by the CDC to document vaccine error by completing a VAERS form.
pt stated that he always tracks his heart rate.  Before taking the vax it was 75.  After taking the vax his heart rate 111.  He monitored it the entire day.  He went to see his cardiologist the next day on 2/15/2021.  At his doctor appt he was given a EKG.  He did not have normal heart rhythm, he was having Atrial fibrillation .  The doctor prescribed new medicine, metoprolol, for him to take along with the other medicine he is currently taking. Pt was told after taking this medicine if he wasn't back to a normal heart rate by 2/17/2021 to come back and he would a cardioversion.  Pt went back to the doctor on 2/16/2021 to do another EKG and his heart rate was back down to 63.  Doctor cut his the metoprolol dose in half and finish the prescription.  He is scheduled to go back to the cardiologist on 3/15 which is the next day after his 2nd dose of covid vax.
Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Medium, Additional Details: Patient experienced syncope and fell face down onto the floor at the rx dept area. After vaccinating, i advised patient to have a seat on the chair for 15 minutes, but after 5 minutes, patient stood up and moved to the pick up line in the rx dept. and at that time, he fell face down onto the floor. I had him to ly down with both legs elevated for 30 minutes and he was back to nor mal. I asked and he stated he didn't have any cut on the lips or any broken teeth. patient is on Chlotharlidone 25mg
On day 8 after vaccine my left arm was swollen, red & very itchy. I put hydrocortisone cream on it & took antihistamine for about 3 days & it was better each day. It took about a week to get normal.
Narrative: 82yo died at outside community hospital on 8/24/21. Pt was in active treatment for prostate cancer with plan for hospice care but pt had died before hospice was set up. Pt had received covid vaccines on 1/25/21 & 2/22/21. Vaccines are not related to pt's death.
pt recv vax NOV95 & w/in 24hr pt exp chest & throat tightness; sx resolved w/in 24hr;
COVID-19 Infection resulting in Fatigue, Heahache, Body Ache, Congestion, Coughing.  No reported Anosmia or Hypoguesia.
chills; slight fever of 99.5; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (slight fever of 99.5) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 UNK. On 14-Mar-2021, the patient experienced CHILLS (chills) and PYREXIA (slight fever of 99.5). At the time of the report, CHILLS (chills) and PYREXIA (slight fever of 99.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: increased (High) temperature went up just a little bit but not a lot.. On an unknown date, Body temperature: normal (normal) Today, his temperature dropped to normal..         No concomitant medication details were provided. No treatment medication details were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Extreme migraine starting at 3:00am. Took 600mg of Ibuprofen at 6:45 am.  Visited Health due to increasing pain and intensity and received shot of Toradol at 8:50 am. Symptom relief at 10:00am and dull headache for remainder of the day. Took 600mg Tylenol at 7:30 pm.  ***Have never suffered a migraine or any headache such as this prior.
Pfizer vaccine was reconstituted with the wrong amount of diluent. 1.4ml was added to vial instead of 1.8ml. Patient received a higher concentration then required.
About an hour after her flu shot she had a tickle in her throat. Then she started itching all over, and said she might need some BENADRYL. As employee was opening the cupboard to get the BENADRYL, pt started slowly going to the ground. Employee yelled for help and the PA came around and saw pt on the floor. I heard nurse ask for the EPIPEN which is when I went to see what was going on. At that point Dr and her resident were in the lab starting O2 with a neb. Pt has upper wheezes, could not talk, and making short gasping breaths. We offered to call 911 but pt wanted us to wait. As Dr was asking questions her responses got slower and we thought she was going to pass out but she came back  We did 2 neb treatments with O2, then saline with O2. Kept her sitting in a room until the end of the day.
She does have a significant muscle ache and joint ache; She does have a significant muscle ache and joint ache; This is a spontaneous report from a contactable physician (Patient's husband). A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 at single dose (Lot # EH9899) for covid-19 immunisation. Medical history, concomitant medications or past drug history were not provided. She has received the first injection of the Covid 19 Vaccination, she received it 24 hours ago (19Dec2020) and she doesn't have a fever but she does have a significant muscle ache and joint ache. So the question if it is okay for the patient to take anti-inflammatory medication like non-steroidal. Outcome of the event was unknown.
Started with sore arm and headache, progressed to high fever (101). Next day had sores on mouth, which spread all over lips and started sore throat. Fever did not go away without medication. Medication would alleviate it but it continued for 6 days, reaching 102.4.  Pediatrician tested for strep and for COVID, both were negative.  Sore throat persisted after fevers subsided.  Had to finally be prescribed magic mouthwash. Doctor said sores on lips were herpes so prescribed viral medications.  My son never has a sore throat and has never had a herpes sore until after the shot.
Information has been received from a 59 year old female retired nurse with allergies to codeine and DEMEROL and a history of Shingles and herniated disc concerning herself who on 15-JUL-2008 was vaccinated intramuscularly with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included levotyroxine Na. After vaccination the patient woke up with severe high back pain. It was reported that the right side back pain from mid line to side began on 23-JUL-2008. She took ADVIL for the pain. On 28-JUL-2008 the patient saw an orthopedist who said it was nerve root pain and causality mentioned it almost resembled Shingles. She had a trigger point injection. On an unspecified date X-ray was performed and no results provided. At the time of this report, the patient was not recovered. Additional information has been requested.
The patient was only given the liquid component of Pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00519175) and transmitted to Sanofi on 15-Mar-2021.  This case involves a 4 months old female patient who was only given the liquid component of 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ419AA, expiry date: 08-Mar-2022) via intramuscular route in the right thigh for prophylactic vaccination on 12-Mar-2021 (Product preparation issue)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included oral ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) for prophylactic vaccination  It was a case of an actual medication error due to Inappropriate reconstitution technique (latency same day).  The caller stated that a patient was given just the Diluent but not the vaccine and want to know what they need to do now and what were the recommendations. Recently a patient was only given the liquid component of PENTACEL.   At the time of report, no adverse event was reported.  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 interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Rash on back and legs.; Hives on back and legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back and legs.) and URTICARIA (Hives on back and legs) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced RASH (Rash on back and legs.) and URTICARIA (Hives on back and legs). At the time of the report, RASH (Rash on back and legs.) and URTICARIA (Hives on back and legs) outcome was unknown.            No concomitant medication was reported. The treatment information was unknown. Action taken with mRNA-1273 in response to the events were not applicable.
This spontaneous report as received from a nurse practitioner, refers to a patient of unknown age and gender. The patient's concurrent, historical conditions, concomitant medications and drug reactions or allergies were not provided. On 20-AUG-2018, the patient was vaccinated with VARIVAX lot # N023957 and expiration date on 01-SEP-2019 (dosage, route of administration and anatomical location were not reported) and PROQUAD lot # R004439 and expiration date on 12-AUG-2019 (dosage, route of administration, and anatomical location were not reported); both administered for prophylaxis. No adverse effects were reported.
Right after getting the second vaccine I started experiencing headaches, nausea, body aches, I felt like I had COVID. I called my doctor he advised me to take Tylenol and Alleve or Motrin and drink lots of fluid. If I got worse go to the ER.
Nausea, feels feverish, weak & perspiring; Had a "head cold" the wk p/inject;
My mother received the FIRST vaccine about 5:30 pm on Jan 13, 2021.  She did fine and went to bed without any issues at all.  When she awoke the next morning, she had a HUGE fever blister/cold sore on her bottom lip.   She had not had a fever blister in decades.  When she called me, I immediately took her Abreva.  She treated it with that 4-5 times a day for about 7-10 days.  It dried up and has finally gone away.  I just thought this was such an unusual reaction.  After doing some internet research and checking with several doctor friends, they had never seen or heard of this side effect.
Lightheadedness, warm forehead. 911 called - medics evaluated patient. They were heard telling patient that blood pressure and pulse were normal, pt still transported by ambulance.
Fussy during PM & evening-whining. Did not sleep well that evening. About 2AM awoke w/very high-pitched screaming-for 5 min @ most. Since has had "night-mares" which he awakes screaming (not high-pitched) & takes about 5 min to awake.
chest tightness, shortness of breath and  chest pain.All this  symptoms occur during physical activity.
My asthma started acting up a few days after taking the first dose. (Mind you, my asthma was pretty much dormant for many years). Then it started getting worse. I felt like I was getting pneumonia, I was coughing, and it was getting harder to breathe. Then I spoke to my doctor and they prescribed me an inhaler. They also gave me a 3-day dose of a steroid.