chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vertigo; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0167; Expiration date were not reported), via an unspecified route of administration in the left arm on 29Apr2021 12:00 PM (at the age of 60-years-old) as second dose, single dose for COVID-19 immunisation. Medical history hypothyroid and overweight; both from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), cetirizine hydrochloride (ZYRTEC) and fluoxetine; all taken for an unspecified indication, start and stop dates were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP7533; Expiration date was not reported), via an unspecified route of administration in the left arm on 01Apr2021 12:00 PM (at the age of 60-years-old) as first dose, single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient has no known allergies. On 03May2021 06:30 AM (reported as 4 days later), the patient experienced woke up with vertigo and had a bad case that day. Since then the patient experienced several spells throughout the day. No treatment was given for the event. The outcome of the event was recovering; it (vertigo) got better as the day went on Tuesday.
Patient had PPD and Varicella vaccine (dose #2) administered on 4/13.  Patient's mother reports that there was visible redness on the afternoon of 4/13 at the site of both injections.  Swelling and pain noted at the sights on 4/14.  Seen by MD on Sunday, 4/15.  Left arm (site of varicella booster) had 17x12 cm area of erythema, with 6.5cm round, firm induration assoc. with discomfort.  Left forarm with 3cm round area of erythema at site of PPD.  .5cm round induration.
Rash on left arm and warm to the touch/ rash, itching, and warmth at the injection site; Rash on left arm and warm to the touch/ rash, itching, and warmth at the injection site; Rash on left arm and warm to the touch/ rash, itching, and warmth at the injection site; This is a spontaneous report from a contactable nurse. This nurse reported similar reports for two patients. This is the 2nd of two reports. A 65-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Batch/lot number: CK0842, expiry date: 28Feb2022), intramuscular into left arm on 19Jun2020 at 09:06 at 0.5 mL, single for preventative. There were no medical history or concomitant medications. The patient experienced rash on left arm and warm to the touch/ rash, itching, and warmth at the injection site in Jun2020, occurred several days after receiving the pneumococcal 13-val conj vac (dipht crm197 protein). The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020248405 Same reporter/drug/event, different patient
Patient missed the 2nd dose window; Sick for a day; Fever; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (Sick for a day), PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose window) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose window). On an unknown date, the patient experienced ILLNESS (Sick for a day) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 20-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose window) had resolved. At the time of the report, ILLNESS (Sick for a day) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.
19 weeks, 2 days gestation awakening this morning with vomiting and extreme dizziness, unable to retain fluids. Instructed to go to the ER for evaluation of her symptoms.
janssen covid-19 vaccine eua blood in stool  pains in stomach frequent urination
itching on my left arm, face and neck; This is a spontaneous report from a contactable Other Health Professional (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: ELO140, via an unspecified route of administration in the arm left, first dose on 28Dec2020 16:15 at a single dose for Covid-19 immunization. Medical history was none, she had no known allergies. There were no concomitant medications. The patient was not pregnant. The patient did not receive any other vaccine within four weeks prior to covid vaccine. She had no covid prior vaccination nor was she tested post vaccination. The patient experienced a little itching on her left arm, face and neck, but other than that, nothing else, all on 28Dec2020 at 04:30 PM with outcome of recovered in Dec2020. No treatment received for the event.
HCP stated that they gave the Booster shot with a temperature excursion to 5 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients). On 10-Dec-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.   This case was linked to MOD-2021-408599, MOD-2021-408463 (Patient Link).
This spontaneous report was received from a pharmacist refers to a 69 year old female patient. On 06-FEB-2013, the patient was vaccinated with a dose of 0.65 ml of live ZOSTAVAX (lot # H019998, expiry:02-FEB-2014) subcutaneously in the left arm. On 09-FEB-2013, the patient experienced tingling, sharp pain 3 days after vaccination which started in the back area and now (more than 2 weeks post vaccination) moving to hip area. No treatment was received. Patient sought medical attention(contacted pharmacy). No laboratory diagnostics studies were performed. The outcome of tingling, sharp pain 3 days after vaccination which started in the back area was reported as not recovered. The causality for the event was live ZOSTAVAX was unknown. Additional information has been requested.
Whole left side went numb, like I have paralysis; still feel it that tension on my shoulder or my left side and on my arm a little bit and it's not like same; it really took me out; I didn't have much energy on to do so much and then I have to constantly lay down; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EW0151) via an unspecified route of administration on 04Apr2021 (at the age of 65-years-old), as dose 2, single for covid-19 immunisation.   Medical history included gastrointestinal cancer metastatic from 2004 to an unknown date. Reporter stated that Gastrointestinal Cancer, that was 17 years ago, coming 17 years, in November, would be her cancer free. She reported that 2004, she came up with stage 4 cancer and its okay gastrointestinal cancer and that was 2004 and then last year, 2020. The patient's concomitant medications were not reported. It was stated that she had whole left side went numb, like she has paralysis and that lasted, she felt much better now but she could still feel it, that tension on her shoulder or her left side and on her arm a little bit and it's not like same, like she stated that had paralysis and yes it really took me out. She had to lay down, she didn't have much energy to do so much and then she had to constantly lay down but her doing much better, you know, she didn't go to doctor and didn't go to hospital because she knows the shot was in, there is nothing they could do about it and she thought, okay. She thinking positive, at least, she got two shots, you know, she stated that 14 years ago, she had stage 4 cancer and it was, she had a port put by the chest or shoulder top, that they could turn around and put the chemicals, chemo any and that was on her left side so, maybe that she whole left side was, her right side was okay and everything was functional, but her whole left side, half of her, half body was just numb. The patient did not receive any treatment for the events. The outcome of the events was unknown.  No follow-up attempts were possible. No further information was expected.
Information has been received from a Registered Nurse (R.N.) concerning a 26 year old female with no medical history or concurrent condition who on 19-AUG-2009 was vaccinated intramuscularly in the left deltoid with the first 0.5 mL dose of GARDASIL (lot# 662404/0312Y). There was no concomitant medication. The patient felt faint within a minute after vaccination on 19-AUG-2009. The patient did black out for about 10 seconds. Afterwards, she was sat down with her legs raised and ice was applied to her neck. The patient also mentioned that she did not eat anything that morning. The patient had recovered from the experience on 19-AUG-2009. Additional information has been requested.
The patient experienced a 7 second syncope episode after administration.  The patient experienced this with the first dose in the series too. The issue resolved on its own and the patient was released.
chills; nausea; had mild allergic reaction; shortness of breath; rhinitis; This is a spontaneous report from a contactable pharmacist reported for self. This 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Left arm on 07Jan2021 13:30 PM on left arm at single dose for COVID-19 immunisation. Medical history included asthma, seasonal allergies. hypothyroid, IBS and known allergies: corn, yeast. Concomitant medications included ascorbic acid (VITAMIN C), vitamin d3, magnesium, probiotic. No other vaccine in four weeks. He had mild allergic reaction on 07Jan2021 13:45 PM, after receiving first dose on 07Jan2021 13:45 PM, shortness of breath for about 1 1/2 hours, rhinitis on 07Jan2021 13:45 PM; also had chills/nausea for about 3 hours starting right after receiving vaccine on 07Jan2021 16:30. No Covid prior vaccination. No Covid tested post vaccination. No treatments were received. Outcome of the event shortness of breath recovered on 07Jan2021 15:15. Outcome of other events were recovered on 07Jan2021.  Information on the lot/batch number has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 03-DEC-2013, the patient was vaccinated with PROQUAD. No co-suspect and concurrent therapies were reported. The pharmacist reported that an unspecified patient was administered a dose of PROQUAD on 03-DEC-2013 instead of the intended MMR II. The patient's first dose of VARIVAX was administered in an unspecified date 3 months ago, approximately in September 2013. No adverse effect reported. Additional information has been requested.
Initially started itching within 20 minutes of injection. Then rashes developed on left forearm, buttocks, and upper back. Overnight had rash and hives, headache, bodyaches, and chills.
Patient presented  with altered mental status and shortness of breath. She has a diagnosis of Covid (+) with hypoxia and UTI.  Patient was initiated on  Ceftriaxone 1g iv q24h, Doxycycline 100mg po bid and Remdesivir 100mg iv q24h.
Pfizer Gray cap administered 25 days past the BUD of 04/20/2022. Pfizer contacted and extended BUD to 04/22/2022. Revaccination recommended.
Suffocating chest congestion, shortness of breath, lack of stamina, cough, low oxygen saturation level rales...continual through present. Treatments included thus far antibiotics, nebulizer, prednisone.  Problem is slightly better but not cured.
PT INITIALLY PRESENTED WITH RAISED REDNESS AT THE INJECTION SIGHT AND MODEREATE REDNESS 2 TO 3 INCHES AROUND THE INJECTION SIGHT.  BENADRYL WAS RECOMMENDED AND TO SEE A DOCTOR IF THE SWELLING AND REDNESS WORSENS AND/OR PAIN AND NUMBNESS OF THE HAND AND FINGERS STARTS.  4 DAYS LATER PT HAD GONE TO A URGENT CARE AND RECEIVED A STEROID SHOT AND ORAL PREDNISONE AND KEFLEX. THE SWELLING AND REDNESS HAD INCREASED TO ENCOMPASS THE ENTIRE ARM.  5 DAYS LATER AND THE REACTION HAS RESOLVED.
Day of administration, she heard a pop and it was painful during the injection, since then her arm has been painful, limited with use. Left deltoid area with some anterior swelling and tenderness. Hurts to move the arm. No redness at the area.
On 12/09/00, this patient had an onset feeling; feverish, broke out in a rash and had generalized joint pains. On the evening of 12/10/00, the rash extended to her face, chest, abdomen, and upper arms. She returned to work 12/14/00.
Initial case received on 05 February 2010 from a health care professional, who was also the patient's mother. An 11-year-old female patient received a first intramuscular injection of ADACEL (sanofi pasteur ltd lot number C3257, sanofi pasteur inc lot number U3042AA) and a first intramuscular injection of MENACTRA (lot number U3069AA) on 18 January 2010. The patient had a history of macrohydrocephaly and "GI issue", and was taking ZANTAC and MIRALAX concomitantly. On 21 January 2010, three days post vaccination, the patient developed severe diarrhea which lasted for 6 days. On 26 January 2010 she developed severe headaches which were still ongoing. She also complained of leg weakness, which lasted approximately 48 hours. A CT scan and blood work were performed, and results were reported as normal. The patient was seen by her physician; at the time of the report, the headaches had not yet resolved.
face had turned completely red; sore neck; Headache; Dehydrated; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9263), via an unspecified route of administration, administered in arm left on 20Feb2021 14:13 (at the age of 60-year-old) as dose 1, single for COVID-19 immunisation at Public Health Department. Medical history included type 2 diabetes mellitus for a long time. He took medication for his Type 2 Diabetes mellitus and was on the medication for a while. The patient concomitant medications were not reported. The patient had not administered additional vaccines on same date of the Pfizer suspect. Prior vaccinations within 4 weeks was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. On 20Feb2021, patient experienced face red, sore neck, headache immediately after receiving the COVID-19 Vaccine. The patient and his wife both got their first Pfizer COVID-19 Vaccine shot last Saturday (20Feb2021). He clarified he and his wife are scheduled to get their second COVID-19 Vaccine on 18Mar2021. He said when he got his COVID-19 Vaccine, his face had turned completely red, and then he went to having a sore neck, and had a headache for 2 days. He said his wife woke up yesterday morning (25Feb2021), 5 days after getting the COVID-19 Vaccine, with a stiff neck, and a sore left arm pit, and a swollen bump in the middle of her left arm pit. He clarified his wife received her COVID-19 Vaccine in her left arm. The patient said his wife wanted to know if anyone else had reported the same side effects that she had. The patient did not go to a doctor or an emergency room because he had to be monitored for 15 minutes after he received his COVID-19 Vaccine. He notified the COVID-19 vaccination site staff he had an issue and was sent to EMS staff to be monitored further. He said the EMS staff told him he was probably dehydrated. He told the EMS staff what medications he had been taking and the EMS staff had told him his medications were not a problem. Therapeutic measures were taken as a result of face had turned completely red, sore neck, headache. The patient took 2 Tylenol, clarified as generic brand Acetaminophen 500mg tablets (NDC Number: 30142-507-83, Lot Number: OBRO474, Expiration Date: Nov2021). His face stayed red for about 45 minutes to an hour, his sore neck was gone by Saturday evening at about 8:30PM-9:00PM, and his headache was gone by Monday, 22Feb2021. He said his wife declined to complete a report over the phone because she had to go to work. The caller said since his wife had to leave for work, she did not have the time to be transferred to Pfizer Medical Information to have her question answered. He said his wife would call back Pfizer Medical Information tomorrow to ask her question. No relevant tests were done. The outcome of the event face red sore neck was recovered on 20Feb2021, headache recovered on 22Feb2021 and unknown for dehydrated.   Follow-up attempts completed. No further information expected.
anaphylaxis; This is a literature report.  A 32-year-old female patient received BNT162b2 (BNT162B2), on 15Dec2020 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 15Dec2020, outcome "unknown", described as "anaphylaxis".  Clinical information: The Regulatory Agency (RA) was the first to authorize emergency use of the PfizerBioNTech mRNA vaccine. On December 8, 2020, within 24 hours after the start of the mass vaccination program for health care workers and elderly adults, the program reported probable cases of anaphylaxis in two women, 40 and 49 years of age, who had known food and drug allergies and were carrying auto-injectable epinephrine. On December 11, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the PfizerBioNTech mRNA vaccine, and general vaccination of health care workers was started on Monday, December 14. On December 15, a 32-year-old female health care worker who had no known allergies presented with an anaphylactic reaction within 10 minutes after receiving the first dose of the vaccine. The participants who had these initial three reported cases of anaphylaxis would not have been excluded on the basis of their histories from the mRNA vaccine clinical trials. Since the index case, several more cases of anaphylaxis associated with the Pfizer mRNA vaccine have been reported after vaccination of almost 2 million health care workers, and the incidence of anaphylaxis associated with the Pfizer SARS-CoV-2 mRNA vaccine appears to be approximately 10 times as high as the incidence reported with all previous vaccines, at approximately 1 in 100,000, as compared 1 in 1,000,000, the known and stable incidence of anaphylaxis associated with other vaccines. The EUA for the Moderna mRNA vaccine was issued on December 18, and it is currently too soon to know whether a similar signal for anaphylaxis will be associated with that vaccine.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event anaphylaxis and the use of suspect product BNT162B2 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202200902646 same aticle/drug/event and different patient;
RSV neg-WBC 8-CXR nl-BC pending;mom reported pt became apneic,t102.6R, lethargic, cyanotic generalized over body;02
Arm is sore near site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 9974P, expiry date unknown) for prophylaxis.   On 19th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 19th September 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 69 or 70 years. The patient received Shingrix in right deltoid and her arm was very sore till the time of reporting. The arm was sore near site of injection, it was not red nor swollen. The reporter consented to follow up.
Initial report received on 13 January 2010 from a consumer. A 55 year old female patient received the INFLUENZA VACCINE (lot and manufacturer not provided) on an unspecified date at her place of employment. An unspecified amount of time later after receiving the vaccine, the patient became sick with Flu-B per an unspecified test. The patient was started on TAMIFLU. It was also reported that the patient not feeling well. The patient had reported history of diabetes mellitus type two, however an onset date was not provided. The patient was told she could go back to work the next day. At the time of the report, the patient was not recovered. List of Documents held by Sender: none.
This case was reported by a consumer via call center representative and described the occurrence of influenza in a 86-year-old male patient who received SHINGRIX for prophylaxis. In January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza. On an unknown date, the outcome of the influenza was recovered/resolved. The reporter considered the influenza to be unrelated to SHINGRIX. Additional information was received as follows: The case was reported by the patient's wife. The reporter stated that the patient presented back to the pharmacy to receive the second shot and the pharmacist denied stating that he was beyond the timeframe. The reporter stated the cutoff date he noted was 22nd July 2018. The reporter noted the reason for the delay of the 2nd dose of SHINGRIX was due to medical reasons. The patient had the flu about 1 to 2 months before the reporting date. The reporter denied any relationship to the SHINGRIX vaccination. The reporter would have the pharmacist call back to GlaxoSmithKline for discussion on the delayed time. This case has been linked to the case US2018143099 (wife's case), reported by the same reporter.
Left arm has a red area 16cm x 10 1/2 cm, swollen. No other urticaria or lesions. Rx: Benadryl 1/2 tsp q 6-8 hrs prn.