chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pharmacist states that a needle separated while administering vaccine; Patient was given 0.2 ml of Moderna COVID-19 Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Pharmacist states that a needle separated while administering vaccine) and UNDERDOSE (Patient was given 0.2 ml of Moderna COVID-19 Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Pharmacist states that a needle separated while administering vaccine) and UNDERDOSE (Patient was given 0.2 ml of Moderna COVID-19 Vaccine). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Pharmacist states that a needle separated while administering vaccine) and UNDERDOSE (Patient was given 0.2 ml of Moderna COVID-19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Approx 10 min after receiving vaccine, pt c/o h/a and dizziness. Paramedic took vitals, pulse and b/p wnl, lungs cta. Provided granola bar and water to pt. Approx 10 min after, client c/o sob. EMS called, paramedic laid pt on floor, O2 via non-rebreather, administered epi injection via autoinjector. EMS arrived and transported pt to ER.  3/1/21- attempted to contact pt, no answer, lvm to return call
Patient returned to clinic 12/6/2008 with complain of redness of right arm. Erythema, extended about 7cm in annular pattern at site of vaccine injection. Warm to touch.
Phlegm in throat; Thought he was not going to be able to breath; similar rash; Hives all over/welt that looked like a spider bite; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Phlegm in throat), DYSPNOEA (Thought he was not going to be able to breath), URTICARIA (Hives all over/welt that looked like a spider bite) and RASH (similar rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced URTICARIA (Hives all over/welt that looked like a spider bite). On an unknown date, the patient experienced PRODUCTIVE COUGH (Phlegm in throat), DYSPNOEA (Thought he was not going to be able to breath) and RASH (similar rash). At the time of the report, PRODUCTIVE COUGH (Phlegm in throat), DYSPNOEA (Thought he was not going to be able to breath), URTICARIA (Hives all over/welt that looked like a spider bite) and RASH (similar rash) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.
headache; Diarrhea; Chills; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 73 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; CHILLS (non-serious), outcome "unknown", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
W/in 12 hours of receiving vaccine pt came down w/chills, body aches and overall not feeling well, extra sleepy.
Within 2 weeks of shot I started to experience elevated heart rhythms multiple times a day when not highly active or resting. I brushed it off as most people do as I didn't think it was related to the vaccine. After having many episodes of over 150 where I was not exercising or being strenuous and finding that my resting rate was now in the 80-90 range regularly (instead of the normal 60-70) I decided to consult my physician and had a blood panel run in November '21. I've never been anemic and am now severely anemic with a 7.5 hemoglobin level and a 3 ferritin. My HR ranges between 85-160 daily. My smart watch has caught a few AFib and inconclusive readings on ECG. I am now requesting a monitor for my heart to document the readings.
Right arm swollen 3"x3", warm with fever; client c/o soreness. Referred to local hospital. Parrent states no test ran at hospital; states hosp. said it was a reaction.
5 minutes after injection my left arm and hand went numb. I  broke out in a sweat. 3 hours after injection my left leg developed numb spots and toes went numb. My muscles felt tight. Numbness subsided hours after. My entire shoulder joint and arm felt like it was on fire,  extreme pain,  could not move without pain.  That night I had chills, stomach pains, headache and some dizziness that has continued into the next day.
Monday am shot given and redness and swelling increase that evening right upper of arm, to fingers . Did not notify MD. Advised to call MD and will "today." Upper swelling has gone down right elbow decrease.  Including swelling Thurs 11/24/05 to fingers.
Covid vaccine monitoring documentation. Patient presented to ED 3/25/21 from home. Patient reported generally not feeling well x 1 week. Patient reported body aches, SOB, difficulty breathing. Daughter reported patient significantly got worse from prior night before arrival until patient woke up. Patient had contacted their PCP and was put on a Zpack which did not have improvement. Patient stated they received their second covid vaccine on 3/15/21, Pfizer EN6204.  SARS-CoV-2 COVID-19 documented positive 03/25/21 16:14. Patient was admitted for monitoring/treatment. First covid vaccine received 2/22/21 Pfizer EN6198, second vaccine received 3/15/21 Pfizer EN6204. Patient received 2 doses but was not 14 days post second dose. SARS-CoV-2 COVID-19 documented positive 03/25/21.
Headache,  injection site pain, muscle pain, body malaise, congested, chills, dizziness, nauseated
Flushed red skin upper torso and face; Flushed red skin upper torso and face; This is a spontaneous report from a contactable nurse (patient herself). A 55-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 18Dec2020 08:00 am in left arm at single dose for covid-19 immunization. Medical history included chronic migraines and allergies: shellfish. Concomitant medication included famotidine, memantine and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patent previously took pethidine hydrochloride (DEMEROL) and experienced allergies.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced flushed red skin upper torso and face on 18Dec2020 13:00 with outcome of recovering. No treatment was received for flushed red skin upper torso and face.  Information on the lot/batch number has been requested.
temp elevated of 101 @ approx 1240PM 28APR98;student c/o h/a & feeling weak @ 9AM 28APR98;
Received An Expired Dose of Heplisav-B; Initial Report Received on 24-Aug-2022  A pharmacist in the reported that a patient (age, gender, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient received and expired dose of HEPLISAV-B.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (expiration date 13-Aug-2022; lot # and NDC # not reported) in an unspecified site, route not provided.  On an unspecified date, the patient received an expired dose of HEPLISAV-B.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
DIZZINESS; NOT FEELING WELL; CHILLS; FEVER OF 100.7; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autism.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced dizziness. On 12-MAR-2021, the subject experienced not feeling well. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever of 100.7. Laboratory data included: Body temperature (NR: not provided) 100.7. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 100.7, dizziness, not feeling well, and chills. This report was non-serious.
No additional AE; HCP calling to report temperature excursion for VARIVAX in which it was administered.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On an unknown date the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number X000100 (is not valid for varicella virus vaccine live (Oka/Merck) (VARIVAX)), 0.5 milliliter for prophylaxis (dose number, route and site of administration and expiration date were not provided) (product storage error and no adverse event).
Has a "pimply thing" on his wrist/ couple of little pimples; Itching like crazy/itching  "started in his hand", extended to his "chest, stomach, lower abdomen area/ woke up itching /mostly itching in his hands; Had a "red rash on the bottom of his right wrist and a little bit on his chest"/ small, light, red, rash on bottom of right wrist; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team. A 70-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 27Jan2021 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included cholesterol, BPH (benign prostatic hyperplasia), blood pressure. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and unspecified medications. Caller stated there were no relevant medications, history or investigations to report, states that he knows they say not to take over the counter medications prior to the vaccine, states that he does take a baby aspirin but has for 20 years. States he takes other prescription medications, for cholesterol, BPH, blood pressure, states these are all under control, takes blood pressure every day. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) as a single dose for COVID-19 immunisation. It was reported that, caller, 70-year-old, stated he received the second dose of the COVID-19 vaccine this past Wednesday morning, on 27Jan2021, on the left arm. He explained during the middle of that night (27Jan2021), he was "itching like crazy" and had a "red rash on the bottom of his right wrist and a little bit on his chest". He specified the itching "started in his hand" and extended to his "chest, stomach and lower abdomen area". Today, he said the "itching has not gone away, there was not much of a rash," he just has a "pimply thing" on his wrist on 28Jan2021, but "the rash comes and goes", it might be there "in 2-3 hours". He mentioned he had no reaction to the first dose. He added that he could not reach his doctor and asked for our recommendations. He also asked if his experience was reported as a side effect of the vaccine. Caller stated that he had his second shot, clarifies of the Pfizer COVID vaccine, on Wednesday, 27Jan2021, states when he got his first shot, he had no problems, states with this second shot he woke up itching like crazy, no rash, no issues or swelling, mostly itching in his hands. Caller wants to know if he should be concerned. Caller clarifies he did have a small, light, red rash on the bottom of right wrist that also has a couple of little pimples, states this rash would come and go. States the itching has now spread from his hands to his shoulders and neck. States he got the vaccine in his left arm. The events were considered as non-serious by the consumer. The outcome of the events was not recovered.
Swollen arm with large red area that is growing. Skin feels hot to touch. Pain in arm where I was not able to lift my arm for 24 hours. Pain in arm has gone down, but the large red area continues to stay large.  Fatigued for the first 36 hours after the injection.
Patient says she had a sore arm first, then it gradually got worse and after 2 days she noticed it felt weak and she couldn't twist her arm or get it above her head without help..  She called her friend, a nurse, who told her it must be a shoulder injury related to the vaccine.  Patient will start physical therapy on 3/30/21.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated by the hospital for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Systemic: Allergic: Itch Generalized-Medium, Systemic: PIMPLES ON THE STOMACH AREA-Medium, Additional Details: PATIENT REPORTING ITCHY BUT NOT PAINFUL PIMPLES AROUND THE STOMACH AREA. SYMPTOMS STARTED ON SATURDAY 1/21/23. PATIENT STILL EXPERIENCING PIMPLES IN THE AREA AS OF 1/29/23. PATIENT BELIEVES IT IS A SHINGLES OUTBREAK AS A RESULT OF GETTING THE VACCINE. HER DOCTOR PRESCRIBED ACYCLOVIR TABS, ACYCLOVIR OINTMENT, AND FLUCONAZOLE FOR HER ON 1/29/23.
08/17/2005 Routine immunizations DTap, IPV right arm. Parent called in following day right arm swollen from elbow to mid arm. Discussed with mother, use Tylenol for discomfort and ice to arm. 08/18 hot to touch continued with treatment. Monday 08/22 mother states much better, no problems now.
Information has been received from a nurse concerning her daughter who was vaccinated with a dose of RECOMBIVAX. Subsequently the patient developed an allergy to hepatitis B virus vaccine rHBsAg, symptoms not reported. At the time of the report the patient's outcome was unknown. The patient subsequently experienced weakness, fatigue and dizziness while on therapy with GARDASIL (WAES #0709USA01032). Additional information has been requested.
Information has been received from a health professional concerning a patient who on unknown dates was vaccinated with PNEUMOVAX. Lot number was not provided. The patient experienced pain, swelling and unable to lift the arm after getting the vaccine. Unspecified medical attention was sought. The outcomes of the events were not reported. This is one of several reports received from the same source. Additional information has been requested.
Several  exposed to temp below freezing (negative) -1.8 C since October 19th; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Herpes zoster (Shingrix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Havrix, Bexsero, Bexsero Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Shingrix, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device and Engerix B. On an unknown date, unknown after receiving Havrix, Bexsero, Bexsero Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Shingrix, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device and Engerix B, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 9-May-2022 Reporter's comments: The reporter stated that, several vaccines were exposed to temperature below freezing negative 1.8 C since 19th October 2022 and were administered to several patients during several days. It was not confirmed if all vaccines were administered. The reporter consented to follow up. Additional Supportive Information: The patients received incorrectly stored vaccine, which led to product storage error.
On day 1-2: severe fatigue and lethargy. On day 10: sudden nighttime urinary incontinence - this has never happened before but both my husband and I have both now had this side effect
No adverse events.  Pt has no concerns.  Patient was inadvertently administered the Pfizer vaccine 14 days after receiving the 1st of the moderna vaccine series, then he received his 2nd moderna vaccine 28 days after his first moderna vaccine (14 day after the Pfizer dose).  Pt does not report any issues.  besides the usual fatigue/soreness that he usually gets after a vaccine
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Medium, Additional Details: Within 15 minutes of receiving the vaccine, pt BP dropped to 97/47 and 37 BPM. Pt was put to lay down on their back with their feet elevated, and their BP and BPM returned to normal levels. Within 15 min from then, pt complained of feeling chills and was strongly shaking. 911 was called w/ pt and relative consent. Pt later left home, returning to normal. Seemed like vasovega response
Swollen lymph node under left arm, redness, swelling. Cellulitis treated w/ doxycycline.
Pt came in for a well exam on 9/25/03 at 9:00 AM and got a DTaP #5 in right thigh. Seen in our office again on 9/26/03 at 4:20 PM, had 4.5 x 2.5cm erythema and swelling on right outer thigh. This started the morning of 9/26/03.
Carbon dioxide narcosis; legs swelling; This spontaneous case was reported by a consumer and describes the occurrence of HYPERCAPNIA (Carbon dioxide narcosis) and PERIPHERAL SWELLING (legs swelling) in an 83-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 reported medical history).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced HYPERCAPNIA (Carbon dioxide narcosis) (seriousness criterion hospitalization). On an unknown date, the patient experienced PERIPHERAL SWELLING (legs swelling) (seriousness criterion medically significant). On 26-Mar-2021, HYPERCAPNIA (Carbon dioxide narcosis) had resolved. At the time of the report, PERIPHERAL SWELLING (legs swelling) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment of the events were not reported.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the pain and product supply issue were unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in early June. As bad as the first shot hurt it was not like the patient was looking forward to the second one but he/she did want to complete the series before the 2-6 months was up. The patient was getting concerned because the 2nd shot had not been available at pharmacists. Which meant it probably was not available anywhere near the patient for the second shot.  Besides that, the patient did not know how excited another pharmacy would be about giving the second shot if I did not get the first one at their place of business.
DRY THROAT, HEADACHE, FATIGUE, CONGESTION, RUNNY NOSE, PERSISTANT NAUSEA FOR 2 FULL DAYS, ARM SORENESS FOR 4 DAYS