chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported pruritus and tender spots on back.  She also complained of fatigue.  Treatment included acyclovir 800 mg five times daily and clobetasol 0.05% topical cream.
daughter's ex boyfriend is also having depression; Brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DEPRESSION (non-serious), outcome "unknown", described as "daughter's ex boyfriend is also having depression"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain fog". Therapeutic measures were taken as a result of depression, feeling abnormal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She has a red rash on her face, neck, back and stomach. She's irritable and itchy and, she has started waking up around 2 am each night (3 consecutive nights) crying, squealing and rolling around for an hour until falling back asleep then whining in her sleep.
Chills; neck/back ache; neck/back ache; headache; This is a spontaneous report from a contactable pharmacist who reported for herself. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 08Jan2021 at 11:30 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none. The patient was not pregnant at the time of vaccination. It was reported that the patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate and zinc oxide (PRENATAL VITAMINS), ascorbic acid (VITAMIN C) and vitamin D3, all taken for unspecified indications from unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Jan2021 at 01:00, the patient experienced chills, neck/back ache and headache. It was reported that the events were non-serious and did not require hospitalization. The patient received treatment for the events which included acetaminophen. The clinical outcomes of the events chills, neck/back ache and headache were recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Narrative:  Patient contacted telephone triage nurse today requesting appt with provider for c/o, "I had a covid vaccine on 2/13/2020, and developed a rash that night - it just keeps getting worse." Patient states he developed a red, itchy rash on his trunk area (both sides) that evening, gradually worsening. States his trunk area is red and "welty" today. Talked to a pharmacist 2 days ago who recommended hydrocortisone cream, "I've been using that, but it's not helping." States redness is getting worse. No pain or blistering. Patient states pharmacist also told him to take otc benadryl, which he is going to try now. No lip or tongue swelling, no difficulty breathing or swallowing. States injection site R arm looks "great."
Received the Vaccine on Sunday 3/28/21 at 3:15pm. Woke up at 8am to a red circle around the injection site on Monday 3/29/21. It was hot to the touch. On Tuesday 3/30 it got noticeably bigger.
pt recv vax 19JUL95 spiked fever that PM; had 90sec clonic sz-8PM; was taken to ER;
I developed shingles approximately 2 weeks after receiving my 2nd dose of the Covid vaccine
The injection was placed into the upper part of my left shoulder. It is normally given in the deltoid but the pharmacist injected the needle into the top of my shoulder. I reacted immediately informing the shot was higher than I've ever received it in my arm and my left shoulder experienced pain immediately. I had difficulty raising my arm above my head, turning the steering wheel on my car, and even buttoning my trousers or moving my belt thru the belt loops. I thought this might have been normal soreness due to a shot but I still was having symptoms and pain 4-6 weeks post injection so I saw my Doctor.
Patient experienced full body hives about 2 hours after receiving the 2nd dose of the vaccine.
Patients reports pain on the interior of her right brachial muscle near the axilla. She says she has trouble lifting her arm and has trouble putting on clothes.
No other AE reported; The patient is 46 years old. He got the 2nd dose on 10/24/2020. He was 45 years old when he started getting the series in June, so he had to get a doctor's note for the other ones since he was outside the age recommendations; Information has been received from a pharmacist referring to a 46 years old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.     On 28-JUN-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, intramuscular for prophylaxis (strength, lot# and expiration date were not provided). On 24-OCT-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, intramuscular for prophylaxis. The patient was 45 years old when he started getting the series in June, and he was 46 years old when he got the second dose, so he had to get a doctor's note for the other ones since he was outside the age recommendations (product administered to patient of inappropriate age). There was no other adverse event or product quality complaints (PQC). The outcome of the events was unknown. The reporter causality assessment was not provided.
From initial information received on 01/Jul/2005 from a HCP regarding an adverse event occurring in the USA, it was reported that a 12 year old male pt received a dose of Decavac, lot number U1563AA, administered IM in the left deltoid on 27/Jun/2005. One day later, on 28/Jun/2005, the pt developed puffy eyes, a facial rash and a rash on his neck and chest. The pt was seen by a physician and was treated with Benadryl and prednisone per os. He was also administered Solu-Medrol 125 mg IM. Per the reporter, the pt did not have any respiratory distress. It was not reported if the pt has recovered from these events. (OMCI)
Lasting 6+ days! Horrible flu-like symptoms: High fever, chills, sweating, headache, fatigue, aching body, nausea, very painful sore throat, runny nose, cough that inhibited sleep. NYQUIL, MOTRIN, and DELSYM cough - Nothing helped - greatly.
Pt received H1N1 nasal mist appx 9:50am. When went back to class became faint. Removed from class, given juice and snack and felt better with good color. BP 112/56, Pulse 56.
The pt developed a fine, red rash over his face, scalp, back, chest, abdomen at bilateral upper extremities. No involvement of lower extremities. No fever or diarrhea. No cold symptoms.
Dazed all morning after immun. Slept for about 1 1/2 hrs then awoke with Unconsolable crying x 1 1/2 hours. Refused feeding then slept x 3 hrs. Shivering and balling and not connecting normally with her environment or mother. Mom reports somewhat quieter than usual not as alert and "slow".
Received vaccination at approx 11:30 AM on 9/27/10. Woke up about 12 hrs. later with chills and trembling all over for about 30 minutes. Followed by extreme warmth all over. Lasted about 1-2 hours.
Information has been received from a female patient who on 15-MAY-2009 was vaccinated with a dose of ZOSTAVAX (Merck). On 16-MAY-2009 the patient experienced redness, swelling, warmth and itching at the injection site. She had not spoken with her physician. The patient did not seek medical attention. No further information is available.
Mom stated child has a raised area where vaccine had been administered. No fever. Mom instructed to apply cool compress and observe for any changes.
My son was given three immunizations on February 20, 2008.  They were Tdap, Hep A, and varicella.  On March 5th he complained his arm was hurting.  One of the injection sites was hot to the touch, red, raised, and a little larger than a 50 cent piece.  The doctor's office said he needed to be seen.  Dr. said it was not a reaction to the immunizations.  She drew a circle around the site and told us to watch it and put him on antibiotics in case there was an infection.  I strongly believe this was a side effect from the immunizations.  He had already had chicken pox but was given the vaccine anyway.  I don't know if this was a good idea.  I am wondering if there is any significance in this reaction and if we should avoid any vaccines in the future.
Patient got SIRVA (Shoulder injury Related vaccine administration); This case was reported by a consumer via interactive digital media and described the occurrence of shoulder injury related to vaccine administration in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced shoulder injury related to vaccine administration. The patient was treated with non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the shoulder injury related to vaccine administration was not recovered/not resolved.   It was unknown if the reporter considered the shoulder injury related to vaccine administration to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's parent who stated that the patient got shoulder injury related to vaccine administration (SIRVA) and was then under going physical therapy.
This spontaneous case reported by a consumer describes the occurrence of COVID-19 symptoms and minor fatigue in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19  vaccine) for COVID-19 immunization. Concomitant products included Metoprolol succinate for an unknown indication. On Apr 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 11, 2021, patient experienced COVID-19 symptoms. On an unknown date, patient had minor fatigue. At the time of the report, COVID-19 symptoms outcome: unknown; and minor fatigue: not resolved. Diagnostic results: On Apr 13, 2021, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Treatment information included Advil. The patient had minor fatigue as of Apr 30, 2021 and no more symptoms. Sender's comments: Based on the current available information, the mechanism of action of mRNA-1237 vaccine and the etiology of COVID-19, the event of COVID-19 is assessed as unlikely related. The event of fatigue is in consistence with the symptoms of COVID-19.
Narcolepsy and cataplexy. Excessive sleepiness and weight gain. Sleeps 18 hours per day. Hospitalized and treated with IVIG. Now on Ritalin. Hospitalized 3/20/10 to 3/25/10.
Woke up with chills, progressed over next 2 days to fever of 101.8; severe headache and vomiting, progressed to diarrhea with abdominal cramping;  received needle on Tuesday August 24 2021 and still feeling some side effects of diarrhea with abdominal upset today Sunday August 29.  Fever diminished, headache diminished, but feeling fatigued and somewhat foggy brain, hungry eating light meals, drinking plenty of Vitamin and/or SmartWater.
Severe 8/10 sensation of substernal chest pain, felt difficult to breath but no dyspena. Pain did not ratidate. EMS called, brought to local ED. Labs found to have an elvated tropinin at 1136.3, EF of 60-65%, normal wall motion, no valvular disease.  IV toradal provided significant improvement. Patient thought to be experiencing myocarditis or arrhythmias and felt to be related to the 2nd dose of the Pfizer COVID vaccine.  Patient admitted to the hospital for monitoring.
Increasing pain and difficulty raising arm beginning 2 days after receiving immunization. Pain continued for 2-3 weeks. Steroids prescribed at week 3. Pain subsided while on oral steroids. Pain returned when course of steroids ended.
cold; tired; Shivering; Severe headache; posterior neck pain; This non-serious case was reported by a nurse via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (Breast Cancer Survivor) and neck pain (little bit of a neck ache on 29-Oct-2023). Previously administered products included Covid 19 shot (unspecified "reaction" to second Covid-19 shot (historical event)).   On 30-OCT-2023 15:30, the patient received the 1st dose of Shingrix. On 31-OCT-2023, 1 days after receiving Shingrix, the patient experienced headache (Verbatim: Severe headache) and neck pain (Verbatim: posterior neck pain). On an unknown date, the patient experienced cold (Verbatim: cold), tiredness (Verbatim: tired) and shivering (Verbatim: Shivering). The patient was treated with ibuprofen (Advil). The outcome of the headache and neck pain were not resolved and the outcome of the cold and tiredness were unknown and the outcome of the shivering was not reported.   It was unknown if the reporter considered the headache, neck pain, cold, tiredness and shivering to be related to Shingrix.     It was unknown if the company considered the headache, neck pain, cold, tiredness and shivering to be related to Shingrix.   Additional Information: GSK receipt date: 02-NOV-2023 The reporter was the patient and she was a retired nurse.  She did not want to provide her exact date of birth.  She reported that on Monday 30-Oct-2023 she had Shingrix shot #1 administered at a pharmacy at around 3:30 pm.  She did not have the lot number for the vaccine but did provide her pharmacy's contact information who should have that information on file. She gave permission for GSK to contact her pharmacy.  She reported that she was not sure if she was having a reaction to Shingrix or if something else could be going on. [She was not sure if she should go to the emergency room or not to make sure she did not had meningitis].  She said, of having some reactions to it.  The patient did not knew whether it from that or something else. She reported of Severe headache and posterior neck pain, shivering last night, cold tired On Sunday [Pre-existing condition] the patient had a little bit of neck-ache, thought that was on the couch in the wrong position watching TV so one side of the neck was stiff. On Monday got the [Shingrix] shot. On Tuesday, was walking around with the grandkids for Halloween with a neckache, It was there a little bit but not bad. She took some Advil. On Wednesday she indicated that yesterday her headache was so bad she felt like someone hit her in the head with a baseball bat. On Thursday she said she was in too much pain to get out of bed right now.  She said only her head and neck hurt, no other part of her body hurts for example her legs did not hurt. The reporter did not consent to follow-up.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-year-old patient of unknown gender. On 13-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
After all 3 shots were given and bandaids were being applied the patient turned white and got light headed.   I grabbed him and laid him down on the table.   Dr came in and checked on him.   We had patient lay there for awhile then he sat up for awhile on the table.   When he felt better he walked to the chair in the room and sat down for the rest of the 20 minutes.    Patient was able to walk out on his own with dad.
clot in her lungs; This spontaneous case was reported by a non-health professional and describes the occurrence of PULMONARY EMBOLISM (clot in her lungs) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PULMONARY EMBOLISM (clot in her lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (clot in her lungs) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event of pulmonary embolism, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-075030 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of pulmonary embolism, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-075030:Patient's brother in law case; cross linked case
pt recvd vax 30DEC94 & 9JAN95 t120-103 & convuls; 10JAN94 still febrile (t103.4); pt requiried no medical visit;
Three months after I got the vaccine I noticed some spots on the left side of my face and on my eyelid. I got a few more spots every day and they were itchy and they hurt. I had some on my eyelid and around the left side of my face.  I went to the doctor on 08/03/2021 and they prescribed an  Antiviral Medication and diagnosed Shingles. I think the spots lasted about two weeks. On 08/19/2021 I thought I had a bad head cold. I went to work and I did not get a cough for a few days. I tested positive five days after it started on the at home test. I went to the medical center the next  day and they gave me an antibody infusion. My symptoms cleared up within a few weeks. I was getting headaches. It cleared up for about six weeks and then I got Sinus symptoms. I was sick for several weeks with the congestion.
The case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 16-year-old male patient who received BEXSERO. Previously administered products included MENACTRA (1st dose received on an unknown date and the patient did not experience any adverse event). Concomitant products included MENACTA. On 19th JULY 2016, the patient received BEXSERO. On 19th JULY 2016, less than a day after receiving BEXSERO, the patient experienced injection site pain, injected limb mobility decreased, sickness, fatigue and weakness. On 20th JULY 2016, the patient experienced general body pain and fever. The patient was treated with ADVIL. On an unknown date, the outcome of the  injection site pain, injected limb mobility decreased, sickness, fatigue, general body pain, fever and weakness were not recovered/not resolved. The reporter considered the injection site pain, injected limb mobility decreased, sickness, fatigue, general body pain, fever and weakness to be probably related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The patient received BEXSERO vaccine in his left arm. The patient felt sick and not well after receiving BEXSERO vaccine. The reporter further described sick and unwell by the specific events like sore arm,  inability to lift arm, fatigue, body aches, fever and weakness. The patient also received 2nd dose of MENACTRA (non-GSK) in his right arm during same doctor visit. The patient did not experienced any reaction after vaccination with previous MENACTRA dose, therefore BEXSERO was listed as only suspect vaccine. The patient attempted to manage the events with ADVIL.
Pt received a Pneumovax 10/20/2004. His right arm was very sore for 2 days and started getting red 10/22/04 and more so today 10/23/04. Red from mid upper arm posterior to Elbow. Edema over olecranon. No fever. pt was seen by MD and advised to apply heat to affected area and given Omnicef 300mg, BID x 8days.
loss of balance and difficulty standing up, dizziness, severe headache, nausea, loss of appetite x5 days, patient reports some improvement, but is still "wobbly" when attempting to stand up
The patient called the pharmacy to inform that she had to go to the doctor because she had some fever and redness on the arm. The diagnosis was cellulitis and was treated with Loratadine and Cefadroxil.
Feel like my head is going ot explode.  Stiff neck, under ears and across left shoulder, cant look down, cant open eyes fully.  Headache across eyes and deep within temples.  Sicky feeling due to the intense pain.  Keeping them closed makes feel bit better.
Body aches, migraine, break out over entire body. dizzy and extreme exhaustion for 6 days
Information has been received on 18-Sep-2003 from a registered nurse concerning an approximately 21 year old female who at 15 months of age and at 9 years of age was vaccinated with MMR vaccine live. In early September 2003 at a visit, the patient had a negative titer for measles. The reporter considered the event as vaccine failure. Subsequently, the patient was revaccinated at that visit. The patient reportedly had no untoward effects." Additional information has been requested.
Entire right side of body swelled up and could hardly move, extreme body aches for 4 days and pain at injection site since injection.