chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little soreness for day or two; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little soreness for day or two) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, LEVOCETIRIZINE and SIMVASTATIN for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (little soreness for day or two). At the time of the report, PAIN (little soreness for day or two) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-102790, US-MODERNATX, INC.-MOD-2021-041143, MOD21-086084 (E2B Linked Report). This case was linked to MOD-2021-103067 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-102790: US-MODERNATX, INC.-MOD-2021-041143: MOD21-086084:
DEHYDRATED; ACHY FEELING; HEADACHE; NAUSEA; TIREDNESS, FATIGUE; CHILLS; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included naproxen allergy, non-smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no drug abuse or drug illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced dehydrated. On 04-APR-2021, the subject experienced achy feeling. On 04-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced nausea. On 04-APR-2021, the subject experienced tiredness, fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dehydrated, achy feeling, chills, headache, and nausea on 05-APR-2021, and was recovering from tiredness, fatigue. This report was non-serious.
pain, swelling. redness, and itching at the injection site; pain, swelling. redness, and itching at the injection site; pain, swelling. redness, and itching at the injection site; pain, swelling. redness, and itching at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sulfonamide allergy.   In February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In February 2020, 24 hrs after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema and injection site itching. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and injection site itching were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and injection site itching to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and twenty four hours later developed pain, swelling, redness, and itching at the injection site.  She stated this lasted for twenty four hours and resolved. She stated she treated her symptoms with half a Benadryl. The reporter did not consent to follow up. The consumer declined to provide demographics other than initials, declined health care professional follow up.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer or other non hcp. A 20-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular route of administration on 26Apr2021 (age at vaccination: 20-year-old, Batch/Lot Number: EW0170) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular route of administration on 05Apr2021 (age at vaccination: 20-year-old, Batch/Lot Number: ER8729) as single dose for COVID-19 immunisation. On 27Aug2021, the patient experienced tested positive for COVID. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): positive on 27Aug2021. No treatment was reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Doctor or other healthcare professional office/clinic visit required for events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient reported tingling/numbness of her right face at the corner of her lips and right temporal area. She did not reports or demonstrate any paralysis. She did not report or demonstrate any cardiorespiratory symptoms.  She was observed for 30 minutes and released in stable condition.  Later that day she reported resolution of symptoms after about 1.5 hours.
severe reaction (vasculitis); Initial information received on 20-Nov-2020 regarding an unsolicited valid serious case from a consumer/non-health care professional via call center.  This case involves female patient (unknown age) who experienced severe reaction (vasculitis), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious severe reaction (vasculitis) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. The patient wanted to know if FLUBLOK is a better alternative.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reports, the outcome was not reported for the event vasculitis.  Information on the batch number to be requested for this case.; Sender's Comments: This case involves female patient (unknown age) who presented with vasculitis, after vaccination with  FLUZONE QUADRIVALENT. Time to onset is unknown. Moreover, concomitant medication, family history, patient medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Redness, swelling, itchy left deltoid 8 days after vaccine given at another facility.
COMPLAINTS OF FEELING WARM SKIN WARM AND DRY FLUIDS GIVEN OBSERVED FOR 30 MINUTES NO FURTHER COMPLAINTS
The patient reports persistent pain localized to the injection site in the left upper extremity that is exacerbated by movement of his left upper extremity with expressed difficulty in putting on shirt, washing back and sleeping on left side. The patient states his symptoms started a few days following his 2nd COVID Vaccine.  He does not have any numbness, tingling or weakness after injection. The area is warm to palpation on exam. He denies any other systemic symptoms.
Soreness at the injection site that felt bruised; Soreness at the injection site that felt bruised and hot; Soreness at the injection site; chills; fever; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Soreness at the injection site that felt bruised), VACCINATION SITE WARMTH (Soreness at the injection site that felt bruised and hot), VACCINATION SITE PAIN (Soreness at the injection site), CHILLS (chills) and PYREXIA (fever) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient prior had Covid before receiving the vaccine.).    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Soreness at the injection site that felt bruised), VACCINATION SITE WARMTH (Soreness at the injection site that felt bruised and hot), VACCINATION SITE PAIN (Soreness at the injection site), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, VACCINATION SITE BRUISING (Soreness at the injection site that felt bruised), VACCINATION SITE WARMTH (Soreness at the injection site that felt bruised and hot), VACCINATION SITE PAIN (Soreness at the injection site), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I woke up at 2:00 am and was experiencing nausea, fever, and chills. I was up from 2:00-4:00 am, and then went to sleep until 12 pm 1/24/2021. I slept for most of the day and then around 7:00 pm on 1/24/2021 I felt better and my fever, and chills were gone. The nausea lasted from 2-4 am, and then stopped, and the fever and chills stopped sometime throughout the day from 12-3 pm on 1/24. I took one NyQuil and did not go to a doctors office or hospital.
I've never had a reaction to the flu shot before. About 14 hrs after this shot, I started cycling thru flu-like symptoms-headache, nausea, runny nose, fatigue, chills and sweating. I also started itching on my left torso and breast. The itching increased over the next few days then on 5th day, I had an initial shingles outbreak. This may not be a direct result of the flu shot, but the doc said the shot may have shocked my immune system so badly that the dormant virus from my childhood chickenpox was triggered.
Patient awoke 10/21/2015 with a large (about 2 inch by 2 inch) rash on left deltoid and 2 smaller rashes near that area.  Patient complained of itching and burning sensation.  Patient went to their doctor's office on 10/22/2015 and was prescribed a Medrol Dose Pack.  Outcome is unknown.
I 'had Covid' beginning Saturday before Thanksgiving.  During that period, I had two tests, both from facility, and both tests came back negative. Symptoms included fever 102-103 for 12 days. No appetite (didn't eat for that duration). Headache. Excessive sweating. Extreme shallow breath. Hyperventilation. Body ache. No loss of smell or taste. No nausea. No mucus response.  Since that time, I have experienced extreme fatigue, weakness, shortness of breath, headache.  After the first shot, those three symptoms increased.  With the second shot, I had fever 99.5-101 from Tuesday though Saturday. Nausea, headache, body ache, weakness, shortness of breath. It felt 85% similar in symptom and intensity as when I 'had Covid'.   The greatest difference is the nausea. When I 'had Covid' there was no nausea and I did not throw up. This time, I had persistent nausea and threw up multiple times in the first three days.
Patient was behind on vaccines and has never had some of the vaccines, according to her shot record. This was her first dose of Hep A, Hep B, MCV4, and MMRV (she has previously had measles and rubella,  but not varicella vaccine or mumps). So mother brought patient in to catch up. Vaccines were given and approximately 5 minutes after as patient was walking out, she appeared to have a seizure and wet herself. EMS was called, it was strongly suggested that mom let them take her to the ER or take her herself, but  in the end mom left with her daughter and it does not appear that child was taken to the emergency room as of yet. The doctor on-call at the clinic contacted mom to encourage her to take her to the ER, but it appears that mother did not take her.
pain in both arms; muscle aches; flu like symptoms; This is a spontaneous report from a contactable physician patient from a Pfizer-sponsored program. A male patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medication included Johnson & Johnson (J&J) DNA vaccine. The patient participated in a J&J vaccine DNA trial 3-4 weeks ago and it had enough time to work. Trial was over. Then he got a call to get the Pfizer vaccine on holiday eve. Got the Pfizer vaccine too 12-14h post dose (unspecified date) had pain in both arms, muscle aches, flu like symptoms, no fever or pulmonary symptoms. Might not need to take a 2nd dose of Pfizer's vaccine because he had a reaction to it. The patient took both the J &J Vaccine and the Pfizer COVID vaccine and he wanted to know if they need to take the second dose of the Pfizer COVID vaccine. He participated in a randomized trial and he completed the trial and knew he got the J&J vaccine. On holiday Eve that his name came up on the list to get the Pfizer COVID vaccine and so he went and got it. He had the J&J vaccine 3 weeks earlier and so he went ahead and got the Pfizer one. Mentioned the J&J vaccine was the DNA vaccine and the Pfizer was the RNA and wanted to know if the second dose of the Pfizer COVID vaccine was needed. He did have significant flu like symptoms with the Pfizer COVID vaccine, which he knew that most people get, but if he didn't have to get the second dose he would prefer not to go through those flu like symptoms as before if he can help it. The outcome of events was unknown.  Information about batch/lot number has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-APR-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 24, 8.7 and R; 24, 9 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
48hr p/vax pt c/o pain, numbness in  upper lt arm;pt mom states had similar local rxn;when was younger p/vax saw MD told to never have Td immun again;
No other systemic s/sx (L) UE rash 10cm x 10cm erythematous patch, mild warmth, no tenderness.
Since the shot I have had paresthesia in extremities and face. It seems to be a type peripheral neuropathy which I am aware has been recorded as being a rare side effect of other vaccines. I found a forum where numerous others have stated they are experiencing the same side effect. It is very concerning and I hope it is not permanent. Please look into this so others do not have to go through this.
spacing for the 2nd dose if a patient has been waiting greater than a year to get dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received greater than a year before).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional Information: GSK Receipt Date: 21-Jul-2022 Reporter's comments: Pharmacist would like to know about the spacing for the 2nd dose if the patient had been waited greater than a year to get the dose. The consent to follow up was given. No additional details were provided. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
nurse from dr's office reported that the patient developed puffy eyes, a torso rash from neck to groin, and a feeling of being sluggish and feverish. symptoms improved with benadryl administration
PATIENT WAS GIVEN 0.25 ML OF MODERNA (ADULT) VACCINE.  NURSING STAFF SPOKE WITH THE PATIENT'S MOTHER TO INFORM HER OF THE ERROR.   PATIENT'S MOTHER STATED THAT THE PATIENT IS DOING FINE.
swelling on arm size of fifty cents piece, painful pruritic, lasted 2-3d; used DPH the first noc since had swelling of arm w/flu shot last year;
Took deadly Vaccine then fell flat on his face.; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age (described as a little boy) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (dose number unknown) for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient "took deadly vaccine then fell flat on his face". The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Hair started falling in clumps; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair started falling in clumps) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced ALOPECIA (Hair started falling in clumps). At the time of the report, ALOPECIA (Hair started falling in clumps) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist, reporting on his wife, a 56 year old female patient. On 17-OCT-2013 the patient was vaccinated with ZOSTAVAX (subcutaneous in the arm; dosage, dose number and lot number unknown). The pharmacist reported that on an unspecified date in 2013 he (MARRS case no. 1411USA005274) and his wife experienced an injection site reaction that "was mild" when they received ZOSTAVAX. He stated that they received the same lot number of ZOSTAVAX on the same day, but he does not have access to the documentation of the lot number report. He states that he and his wife both experienced a "quarter-sized" injection site redness with no pain or swelling. Neither he nor his wife sought medical attention nor received treatment. The outcome of the injection site redness was reported as recovered in an unspecified date in 2013 (reported as: within a couple of days). This is one of three reports from the same source. Follow up information has been received from a pharmacist on 16-DEC-2014. The pharmacist stated he has no access to the lot number for the ZOSTAVAX vaccine he and his wife received. The pharmacist also stated he had no patient identifiers, lots numbers or dates of vaccinations for the other patients he referred to in the original report. The pharmacist had no information to share at this time. Additional information has been requested. Narrative was updated.
Upper arm area swollen; Upper arm area was itchy; Covid arm; Hard circle at injection site that feels hot to the touch; Upper arm area was sore; Large, raised, hard circle at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Upper arm area swollen), PRURITUS (Upper arm area was itchy), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hard circle at injection site that feels hot to the touch) and PAIN IN EXTREMITY (Upper arm area was sore) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PERIPHERAL SWELLING (Upper arm area swollen), PRURITUS (Upper arm area was itchy), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hard circle at injection site that feels hot to the touch), PAIN IN EXTREMITY (Upper arm area was sore) and VACCINATION SITE INDURATION (Large, raised, hard circle at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Product used for unknown indication, at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Upper arm area swollen), PRURITUS (Upper arm area was itchy), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hard circle at injection site that feels hot to the touch), PAIN IN EXTREMITY (Upper arm area was sore) and VACCINATION SITE INDURATION (Large, raised, hard circle at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient post receiving their first dose reported Covid arm and having a large, raised, hard circle at injection site that felt hot to the touch. The upper arm area was swollen, itchy and sore. Reportedly, symptoms started eight days after the vaccine on 26-Mar-21 and the patient thought it was a spider bite until going to the doctor. The patient was put on a topical steroid and Benadryl. On 30-Mar-2021 at the time of reporting, the patient stated that it was not completely gone but getting better.   No Concomitant product use was reported.  Treatment medication included topical steroid and Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Non-Significant follow up appended: Contact information updated
Approximately 2 weeks after vaccine, a 3cm erythematous plaque developed at vaccine site.
Rash dx'd by MD as vaccine induced measles on 3/7/01. Elevated temperature on 3/6/01 and 3/7/01 between 99F (R) and 100F (R). Pt is recovering. BP-98/62.
9/2 came home from school tired and slight fever event up to 100 degrees and vomited 1 time, fever maintained 1 week. Treated with Ibuprofen. 94 degrees; lump under left ear lobe, glands swollen. Sore throat and mouth white. Went to doctor on 9/15/04 and was given Penicillin 3x day 250 mg 3 tabs. Out of school for two weeks.