chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; legs were feeling itchy; red blotches to back of thighs/red blotches to both inner arms/red blotches mostly to both calves; redness to right leg/redness to right thigh/she had redness, flushed and warmth of face; stated that all the flushed areas were hot to touch; redness to face (flushed)/she had redness, flushed and warmth of face; she had redness, flushed and warmth of face; moderate allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) via an unspecified route of administration in the right arm, on 07Jan2021 at a single dose, for COVID-19 immunization. Relevant medical history included right eye surgery on 06Jan2021, severe allergies, environmental and drug allergies. The patient has no concomitant medications. The patient stated that she had first dose of COVID vaccine on Thursday. Stated that she has sent V-safe reporting updates. Stated that she had a moderate allergic reaction to the vaccine on an unspecified date in Jan2021. She had noticed hives when she woke up on Friday morning (08Jan2021) that her legs were feeling itchy. She stated that she has hives, red blotches on back of thighs, arms and mostly on calves. The area was hot to touch. She then clarified that all the flushed areas were hot to touch. She was feeling a little better. She stated that they looked like they were trying to dry up and she has new ones. She had redness, flushed and warmth of face that started the day of vaccine that night (07Jan2021). She had red blotches to back of thighs Friday evening and they were starting to fade. Stated that the blotches to her left leg started Friday and that evening redness started to right leg and thighs. The blotches to both calves are still warm but starting to improve. The redness to her right thigh is more pink than red now. The patient was Benadryl around the clock and using Aveeno cream as treatment for the events. She has always had severe allergies but has not had an allergic reaction in over year. She also has history of environmental and drug allergies. Patient was trying to determine if should go back for second vaccine due to the reaction. She had asked for a consult from the immunization doctor before receiving the vaccine because she has history of severe allergies. Outcome of the events hives, and redness was not recovered, for events flushing, hot flushes, and red blotches was recovering, while for the remaining events was unknown.
10/8/10 - "not himself" but no symptoms of fever until 10/9/10 - started with fever at AM, up to 103-104 degrees F, not lowered totally with acetaminophen. Diarrhea on 10/11/10 - 2 loose BM, no blood, no mucus x 1d. Rash-erythematous - diffuse affecting face, trunk/limbs, mild papules. Rhinorrhea (AM 10/10/10). Child seen in office on 10/11/10.
Information has been received from a registered nurse concerning a 20 year old female with no pertinent medical history or drug reactions/allergies who on 14 Nov 2006 was vaccinated intramuscularly with HPV Vaccine. There was no concomitant medications. On 15 Nov 2006, about 24 hours later, the patient developed erythema at the injection site and experienced flu like symptoms. Unspecified medical attention was sought. Subsequently, the patient recovered from the erythema at injection site and flu like symptoms within 72 hours. Additional information has been requested.
Information has been received from a 63 year old male pharmacist who in September 2011, was vaccinated with the first dose of RECOMBIVAX HB (Lot #, dose and route not reported) and in October 2011, received the second dose of RECOMBIVAX HB (lot #, dose and route not reported). On 01-DEC-2011, the patient developed an allergy to potatoes, tomatoes, coffee and bell peppers and hives all over his body when he ate any of these products event tomatoe sauce. The patient did not know if the allergies were related to RECOMBIVAX HB or not. The patient was seen by the allergist who tested him and the patient was positive for nightshade family of plants. No treatment for the AEs was given. At the time of the report, the patient did not recovered. Additional information has been requested.
rash throughout torso, red pin point and welt, very itchy no blisters rash on arm date of 2nd vaccine below shot site  oral benedryl , topical aspercreme with lidacane
The doctor warned me of a fever related to the vaccine that could occur a week after the shot.  On July 2nd, 10 days after the shot, my daycare called me to report a fever of 101.6.  That evening, I found chicken pox like blisters on her arm and leg.  The following day, I found more blisters (smaller) on her chest.  Her fever has since been between 'normal' and 101.3, as of this morning (5am), July 4th.  Temperature was recorded from under her arm 100.3, so I added a degree since it was auxillary.  Her diapers have had looser stools than normal, and she seems to be napping more frequently.  Her appetite seems to be OK, and her fluid intake is good.  She is not lethargic, but her unusual fever and the blisters leads me believe that it is caused by a reaction to the vaccine.  I called the doctor's office twice and they have been helpful.
8/15/2021 SEEN AT MEDICAL CENTER ER. REPORTED DRY COUGH, FATIGUE.  8/18/2021 RETURNED TO MEDICAL CENTER ER. REPORTS FATIGUE, COUGH, MELAISE, POOR PO INTAKE PROGRESSIVE DYSPNEA.UNABLE TO CARE FOR HIS WIFE (PATIENT IS THE PRIMARY CARE GIVER) DUE TO HIS CURRENT ILLNESS.  DX; PNEUMONIA. O2 SAT IN LOW 90s ON 3 L OF O2. PATIENT ADMITTED TO INPATIENT HOSPITAL ON 8/8/21.  AS OF 8/26/21 PATIENT NOW ON BIPAP.  STATUS POST REMDESIVIR, TREATMENT CONTI WITH DECADRON, BARICITINIB, LOVENOX, ROCEPHIN STATUS POST AZITHROMYCIN. PATIENT IS CURRENTLY HIGH RISK FOR DECOMPENSATION.
This spontaneous report as received from a consumer refers to a female patient of unknown age. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with GARDASIL injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. On an unknown date, the patient experienced blurred vision after receiving GARDASIL. The outcome of vision blurred was unknown. There was no product quality complaint (PQC) involved. The reporter's causality assessment was not provided. Additional information is not expected, no contact details were provided.
pt became pale c/o nausea, was very lethargic, chills but no fever, had petit mal sz 1 1/2hrs p/vax;seen in hosp ER on 7OCT95 & saw MD;lt eyelid was swollen 8OCT95;
losing night time sleep; welts on his body; rashes on delicate parts of belly, buttocks, scalp which were itchy/The rash gradually developed an itch; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899 and expiry date: 31Mar2021), via intramuscular route of administration on 30Dec2020 at 11:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021, a week after the injection, the patient experienced rashes on delicate parts of belly, buttocks, scalp which were itchy. The rash gradually developed an itch and he is now losing night time sleep. Patient stated that there were welts on his body on an unspecified date. He tried everything to stop the itch. He later stated there were objects across the counter that he tried, not prescription. One was alcohol and the other one was peroxide and a third one is Jergen's hand lotion and none worked. The outcome of the event itchy rash was not recovered, while unknown for the other events.
pt recv vax 8MAY97 & 10JUL97 pt exp a sz;pt has been on a roller coaster & began sensing a sz coming on;grand mal sz;pt did not sleep more than 3-4 hr the noc prior to sz;
sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6201) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. Consumer stated, patient had first shot 3 weeks ago, and patient had a sore arm which was fine. patient had second shot yesterday and patient, arm isn't even as sore as it was it was from first one and I have no other symptoms. Does that means patient have a dud? The outcome for event was unknown.  Information of Batch/ Lot number have been requested. Follow-up attempts are completed. No further information is expected.
Later the same day as vaccines given, patient developed warm erythematous blotchy rash of (L) upper arm, just distal to injection site. Parents treated with po Benadryl, Cetirizine. Had significantly improved by time of office evaluation 9/30/19.
Patient received dose in right arm with no complications.  However, about 1-2 minutes after vaccination patient reported feeling lightheaded.  As I was instructing her to remain seated, she passed out and was unresponsive.  She appeared to be having a seizure immediately after that lasted about 1 minute.  Once this episode passed, she became responsive and could talk.  EMS arrived and took over.
1. Swollen lymph node near collar bone. Lasted for 3 months.  2. Currently my period is about 10 days delayed (not pregnant and it?s the first time it is delayed. The vaccine was taken 5 days after of the beginning of the last period.  Do t know if it?s related but thought that it might be
130mm x 90mm erythema;local rxn: distal arm edema alone, or distal arm edema plus extensive inj site red;
GARDASIL 0.5 ml lot K008213 was administered on 02/04/15 to left deltoid. Mom called 02/09/15 to report his left arm became red, swollen and warm to touch at site of injection and spread quickly down his arm. She gave him BENADRYL on 2/4/15 and he was better. He's had BENADRYL over weekend.
Information has been received from a registered nurse concerning "2 or three out of five" elderly male patients "usually in their 70's," who, on unspecified dates, were vaccinated with doses of pneumococcal 23v polysaccharide vaccine (Lot# 658555/0964U). It was reported that most of the patients were previously vaccinated with pneumococcal 23v polysaccharide vaccine five years ago or more. Subsequently, the patients experienced swelling, pain, and tenderness in the injected arm. It was reported that the symptoms would sometimes spread to the underarm. The patients either called the office or were seen at the office. The patients were advised to use ice and TYLENOL if necessary. The patients recovered on unspecified dates. No product quality complaint was involved. This is one of five reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Hive like rash from site around to bottom x 2 times. After each redness mother states gave BENADRYL and hives gone in one hour.
Patients mother was contacted this morning June 27, 2023 at approximately 8:15 am by a  certified translator for follow up after her daughter received 0.2 ml of undiluted Covid Pfizer vaccine on June 22, 2023 at 6:29pm. the mom stated that patient is doing fine and patient only had mild flu like symptoms after the vaccine. Patients mother denies any serious adverse reactions such as rashes, pain, shortness of breath. the mom advised if patient has any rashes, pain , shortness of breath or other concerning symptoms to call 911 or go to nearest emergency room. The mom verbalized understanding and thanked for care. The mom stated that she understands what happened and she has no questions or concerns.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose and lot # not reported) after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt experienced scalp and facial itching 15 minutes post vax. Pt was given Dimetapp but hives/rash appeared on neck and shoulders 2 hours post vax. Pt was treated with Benadryl.
About 4 AM on 3/10 I woke up with upper abdominal pain. This pain was relieved by an Alka Seltzer. Upon arising on 3/10 I still had mild upper abdominal pain. It worsened and was relieved to some extent by antacids. It persisted throughout the day and evening and was worsened by eating a cheeseburger. Mild food, such as toast or cream of wheat seemed to help. 3/11 was the same. 3/12 has been a bit better, but I still have some mild upper abdominal pain.
Leukemia; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 82 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization; Bnt162b2 (dose 2), for COVID-19 immunization. The following information was reported: LEUKAEMIA (medically significant), outcome "unknown", described as "Leukemia". The patient underwent the following laboratory tests and procedures: antibody test: negative. Therapeutic measures were taken as a result of leukaemia. Caller said that he had all the 3 doses of the Pfizer covid-19 vaccine and got negative antibody response. Caller mentioned that he is currently at clinical trial at (name) for leukemia. Caller asked if he can get a prescription for Paxlovid even though he is not covid-19 positive. Caller also said that he is taking Ibrutinib, and he know that the said drug has interaction to Paxlovid, he said that if ever, he knows that he need to stop his current medication as he takes Paxlovid.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known disease pathophysiology, the event of leukemia is assessed as not related to BNT162B2, and more likely an intercurrent medical condition.
3-4 hours post vax, pt awakened from nap with entire trunk and legs very red. Pt was treated with Benadryl and within 2 hours redness was gone. No swelling, fever of trouble breathing was noted.
staff member gave only the Diluent (Adjuvant Suspension Component) for a Shingrix Vaccine to a patient. No adverse reaction noted. Patient will received full dose of vaccine in the future. Patient any physician were both notified.
Pfizer-BioNTech Vaccine administered/ Paxlovid: Treatment of COVID-19; Pfizer-BioNTech Vaccine administered/ Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number un-known, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Thyroid disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Pfizer-BioNTech Vaccine adminis-tered/ Paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.   Clinical Information as reported: Patient did not receive other medication in 2 weeks. Anti viral details: product=COVID 19 Treatment, brand=Paxlovid, treatment start date=04Apr2022, Indication=Treatment of COVID-19. Adverse event Headache within 1/2 hr to 1 hour of taking dose. Chalky sensation in mouth. No appetite adverse event start date: 04Apr2022 if treatment AE was Unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Erectile Disfunction after five days of receiving vaccination.; This is a spontaneous report from a contactable consumer (patient herself).   A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot Number: ER8727;Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:15 at SINGLE DOSE for covid-19 immunisation.  The patient had no medical history and no allergies to medications, food or other. Concomitant medication included alfuzosin HCL, Atorvastatin calcium, celecoxib.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination.  The patient experienced erectile disfunction after five days of receiving vaccination on 27Mar2021 21:30. The action taken in response to the event(s) for bnt162b2 was not applicable.Treatment was not received for the adverse event.The outcome of the event was not recovered.  More information has been requested.
This non-valid spontaneous report was received from a pharmacist and refers to two unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported). There were no adverse symptoms reported. Administered doses of vaccine experienced the temperature excursion of 18 degrees Fahrenheit for 1 hour and 36 minutes. Data logger was involved. There were no previous excursions reported.
itching/ itching in her head; whelps that were streaks of small bumps on legs, butt, chest and arms; arm redness; warmth; arm soreness; headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On 8th July 2019, less than a week after receiving Shingrix, the patient experienced pruritus and welts. In July 2019, the patient experienced erythema of extremities, feeling of warmth, pain in arm, headache and nausea. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the erythema of extremities, feeling of warmth and pain in arm were recovering/resolving and the outcome of the headache, nausea and welts were recovered/resolved and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, feeling of warmth, pain in arm, headache, nausea, pruritus and welts to be related to Shingrix.  Additional details were provided as follows: The patient had redness, warmth and soreness about 2 to 3 inches below the site of injection. The patient had a slight headache and nausea. On 8th July 2019, the patient awoke with itching and whelps that were streaks of small bumps on her legs, butt, chest and arms. The patient experienced itching in her head. The patient took a bath and that helped the whelps resolved. The patient called the health department, that is where her daughter, an register nurse. The patient was referred to her physician. The patient consented to follow up.
See additional paged for medical records. Particularly details of both visits related to the adverse event. The patient is a 24 year old female who presents with a complaint of headache. The onset of the headache has been sudden and has been occurring on a persistent pattern for 3 days. The headache is characterized as throbbing and a pressure sensation. The headache is described as being located in the back of head. Note for "Headache": Patient state she had three bumps on her head one behind right ear two behind left ear.
Employee presented to PCP on 02/24/22 with ongoing rash. She states the rash started approximately 4-6 weeks after receiving her 2nd dose of MODERNA Covid-19 vaccine on 10/06/21. Employee states she has not reported it until now because the rash is not constant.
Complained of pain at right arm injection site at time of injection and continues to have pain that runs down arm on daily basis.  No fever, no redness at injection site.  Referred to private MD for follow-up.
Reddened area on back of upper right arm, itchy and tight as described by patient.
fever, nausea, & vomiting & diarrhea w/GI upset for 24 hrs following shot;
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
Redness, pain, itching, swelling, hard lump, warmth and bruising.
Low heart rate, lethargic  B/P 67/43  Was taken to Emergency Department for further evaluation.
pt recvd vax & started turning red in the face, got a stuffed up nose & began to feel dizzy; mom took back to clinic;
Presented to ER with abdominal pain, testicular pain, urinary retention, fatigue, decreased reflexes lower extremities and numbness of extremities.