chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt malaise for a day after his first two shots; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt malaise for a day after his first two shots) and PAIN IN EXTREMITY (Sore arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced MALAISE (Felt malaise for a day after his first two shots) and PAIN IN EXTREMITY (Sore arm). At the time of the report, MALAISE (Felt malaise for a day after his first two shots) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported. No treatment information was provided.  The patient reported that post receiving their first dose of vaccine the patient only had a sore arm and felt malaise for a day.   This case was linked to MOD-2021-331183, MOD-2021-331192, MOD-2021-331344 (Patient Link).
Since shortly after the injection she has experienced a low grade headache over her eyes and on the top of her head, similar to a sinus headache.
Rash on chest and neck, developed around 1pm on 2/13/2021, minor irritation (stinging sensation), warm to touch, no itching.
On 6/12/21 I fainted while seated.  After waking from faint I was transported to Hospital.  I was examined and released with no apparent cause for fainting.  I followed up the next week with a cardiologist at hospital Dr recommendation.  Cardiologist also found no apparent cause.  I have not fainted since.  I had the second dose on 11/23/2021 and had no adverse impacts.
The patient is a 35 year old female with PMH remarkable for Chron's disease in remission, seasonal allergies, s/p R adrenal schwannoma s/p resection who presented to the ER with ongoing problem with urticaria for the past 3 weeks. She reports feeling well when she developed scalp itching which progressed to diffuse intermittent hives and angioedema 2 days after receiving Covid J&J vaccination. She has been taking oral steroids, antihistames and h2 blocker for weeks. She reports no improvement in symptoms with these interventions. She also reports itching, but this has progressed to burning and stinging skin. She notes her palms and soles have been sore, and have purplish blotches. Evaluation in the ER was non revealing for a cause but as the patient has been so miserable, admission was recommended for IV treatment. Currently she is standing in her room,
patient states has had a rash since 4-16-21 and called the pharmacy on 4-27-21
1815 parasthesias L tongue/ palate. No other neuro or other symptoms  1900 gradually resolved. Now no symptoms  PS retired ED physician
This case was reported by a consumer via call center representative and described the occurrence of chills in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 5th April 2019, the patient received the 2nd dose of SHINGRIX. In April 2019, less than a week after receiving SHINGRIX, the patient experienced chills, pain and jaw pain. The patient was treated with ibuprofen (Unknown Manufacturer). On an unknown date, the outcome of the chills and pain were recovered/resolved and the outcome of the jaw pain was unknown. It was unknown if the reporter considered the chills, pain and jaw pain to be related to SHINGRIX. Additional case details were provided as follows: The patient received the dose of SHINGRIX and experienced chills, pain and pain in jaw similar to TMJ (Temporomandibular joint). No further information was provided due to the connection lost.
Patient presented to the pharmacy 4/8/2019, stating that shortly after receiving vaccination, has soreness and itching at the injection site. The injection site is also swollen, hard and warm to the touch. Patient denies fever, vomiting, or diarrhea. Does state that experienced fatigue within the first 36 hours post vaccination. Patient has full mobility of affected arm, is able to raise and rotate her arm around without hindrance. The swollen area is getting progressively softer.
19 hours after vaccine, soreness at injection site, fever 99.9 - 100.1 (normal temp for me is 97-98). Fever lasted two full days and could only be brought down by alternating tylenol and ibuprofen.  Extreme swelling of lymph nodes under armpit to the size of a baseball, pain spread through underarm and up to should and left breast tissue.  This lasted 4 days before any relief and then got better over the next few days. It was very uncomfortable.  Then developed a small patch of eczema on my inner left elbow bend. I have never had eczema before but thought it might be a reaction to the vaccine.  It's still there, but getting better 2 weeks later.
Extreme wooziness - collapsed between bathroom and bed; bad muscle aches, overheating and chills
pt recv vax 29APR98 10AM;awoke 5PM tactile fever, w/in 5min found to be bluish, foaming @ mouth & stiff;lasted 3-5min dx in ER w/sz;
ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Nausea beginning 10-12 hours after taking 1st dose oral typhoid vaccine. Vomited, very fatigued. Completed all 4 doses but nauseated after each and slept > 18 hours after dose 2.
shortness of breath; Itching; swelling under the eyes; red blotchy skin; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6203, expiration date was not reported), via an unspecified route of administration, administered in left arm on 04Mar2021 07:15 (at the age of 66-years-old) as dose 1, single for covid-19 immunization. The patient medical history included allergy to sulfa drugs, food allergy to chocolate. Concomitant medications were not reported. No other vaccine received in four weeks. No other medications received in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 06Mar2021: 06:00 AM the patient experienced Itching, swelling under the eyes, red blotchy skin, shortness of breath. These are the same side effects when I take sulfa drugs. Patient took benadryl and used cortisone cream as treatment for adverse event. Therapeutic measures were taken as a result of shortness of breath, itching, swelling under the eyes, red blotchy skin. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Client experienced right sided weakness, mental confusion 12 hrs after receiving flu shot. 11/28/06 Received medical records from hospital which reveal patient admitted 10/25-10/28/06 for final DX: polymyositis exacerbation & TIA.  Had been feeling well until received flu shot 10/23.  He awoke during the night & fell on his way to bathroom.  Continued to have persistent weakness of both upper & lower extremities.  Also had right sided weakness & right facial droop alternating with normal neuro findings. Developed acute pneumonia.  Treated with antibiotics, prednisone & PT.  On 10/28 was transferred to SNF for further PT until final d/c to home on 10/30. FINAL DX: polymyositis flare up; TIA; acute pneumonia; CHF exacerbation; GERD, anxiety; DM type 2./ss
Vaccine administration error. I signed-up for a Moderna booster 0.25mL. The pharmacist gave me a higher than authorized dose: 0.5mL. The pharmacist reported the dose to my primary care MD as 0.5mL. The higher dosage was my 3rd Moderna shot. I was not immunocompromised. To make matters worse, on day 3, I got "Moderna arm," which lasted in varying degrees for 15 days. Even now the injection site aches from time to time.
Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 10-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a 58 year old female consumer with asthma and allergies to penicillin and erythromycin who five years ago (in November 2004), was vaccinated with the first dose of PNEUMOVAX 23. The patient had no reactions after the first vaccination. On 30-OCT-2009, the patient was received the second dose of an unspecified pneumonia shot (possibly PNEUMOVAX 23). Concomitant medication included "several medications" (detail not reported). Within six hours after receiving the second pneumonia vaccine, the consumer had severe chills for several hours, nausea and body aches. These symptoms were ongoing for about fourteen hours. During the week of 01-NOV-2009, the consumer had two to three episodes of nausea that lasted throughout the night and she was not eating. On 08-NOV-2009, 09-NOV-2009, and 13-NOV-2009, the patient experienced chills, body aches and nausea throughout the night. The consumer had felt a little better on 14-NOV-2009, 15-NOV-2009, and 16-NOV-2009 but not recovered. The patient mentioned that she was feeling nausea again during the phone call. It was also reported that the nausea was worse late in the day and into the evening or overnight. The patient did not have symptoms every day, they were had been sporadic in the last 18 days since receiving the pneumonia vaccine. The consumer also mentioned that she had received a seasonal flu vaccine (manufacturer unknown) two weeks prior to vaccination with the pneumonia shot and had no reactions. The patient made a call for medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Hives, progressed to whole body urticarial. Seen in office 4/6/16, treated with Zyrtec and steroids.  Referred to allergist.
Racing heart within 10 minutes; vicelike headache; extreme nausea; pain in fingers and toes; bloody nose; pain in hips; swollen eyes; itching at injection site; no appetite; General weakess; insomnia; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 68-years-old female patient (Non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EN6200), via an unspecified route of administration, administered in Arm Left on 21Feb2021 13:45, as SINGLE DOSE for COVID-19 immunisation. Medical history included colostomy, osteoporosis and seizure (Grand Mal Seizures). The patient had no known allergies. Concomitant medications included felbamate (FELBATOL); levothyroxine sodium (SYNTHROID), lisinopril (ZESTRIL); calcium carbonate (OSCAL [CALCIUM CARBONATE]) and vitamin c [ASCORBIC ACID]). On 21Jan2021, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EL9261), via an unspecified route of administration, administered in Arm Left, as SINGLE DOSE for COVID-19 immunisation. Patient not received COVID prior vaccination. Patient not tested for COVID post vaccination. On 21Feb2021 (13:00), the patient experienced racing heart within 10 minutes; vicelike headache; extreme nausea; pain in fingers and toes; bloody nose; pain in hips; swollen eyes; itching at injection site; no appetite; general weakness; insomnia. Patient not received treatment for the events. At the time of this report event outcome was recovering.  No Follow-up attempts are needed. No further information is expected.
Had almost as bad reaction as the first one to the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had almost as bad reaction as the first one to the 2nd shot) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had almost as bad reaction as the first one to the 2nd shot). At the time of the report, VACCINATION COMPLICATION (Had almost as bad reaction as the first one to the 2nd shot) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-080257 (Patient Link).
day after vaccination patient woke up with dizziness, nausea, lethargic. This lasted for 2 days.
Pt. did not report this until today 1/23/13 when she asked if OK to get 2nd dose of Hep B. Within 1 hour of receiving 1st dose 2 months ago, the injection site became itchy, then other areas began to itch - both arms & neck. Noted red bumps in some areas, then hives with itching. No hives on trunk. Took BENADRYL x3 over the next 24 hours & symptoms resolved by the following night. Did not see a doctor. Advised not to receive any more Hep B vaccine. Unless authorized by a doctor.
Inappropriate schedule of vaccine administered(18Jan2021/ 23Feb2021); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(18Jan2021/ 23Feb2021)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 042120A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included VALSARTAN for Blood pressure, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for Reflux gastritis, VITAMINS NOS, POTASSIUM CHLORIDE, COLECALCIFEROL (D3), CLONIDINE, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL-D) and DILTIAZEM for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(18Jan2021/ 23Feb2021)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(18Jan2021/ 23Feb2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taking a medicine to help digestion and another medicine to help gut be more normal.   This case was linked to MOD-2021-311012 (Patient Link).
On 8/19/07 approx 8:00 AM the following morning I had deep aching pain in upper arms. Went back to emergency room. I was checked and doctor said I had an allergic reaction to Tetanus shot. Gave me pain medication and prescription. /15/07-ER records received for DOS 8/18/06- Presented to ER with fish hook in right small finger. Denies any numbness or tingling.Fish hook removed. Keflex prescribed.  10/10/07-office notes received, note for DOS 10/24/06-C/O left shoulder arm pain radiates to hand symptoms for 2 days. On 10/3/06 C/O bilateral leg muscle pain all the time since August.  Follow-up: Received shot on 8-19-2006 (Friday) on Sat 8-20-07 woke up and my arms (upper) had a terrible hurting like my body were breaking. 1/11/2010 Muscles have wasted in left arm (where vaccine was administered) Still has aching in muscles. At time hard to use arm, burning sensation in back along spine. Sometimes I am disoriented. Follow-up Information 12-DEC-2008: I have went down hill-health wise since receiving vaccination and cannot seem to recoup with muscle and nerve changes. 02/02/2010 My muscles in my arms are wasted and I have deep severe pain in my upper arms. I have wnet down hill since the vaccination including hospitalization.
Day of injection my arm was extremely sore, swollen, hot. I developed a headache which lasted for 2 days. No energy, unable to raise my arm above my head. Lymph nodes enlarged. Day 3 all symptoms had passed except my arm is lumpy, hard, sore and has a rash extending around 2" from the injection site. Day 4 the area is now spreading down to my elbow and is itching. I have kept it clean, no bandage and am taking an antihistimine with some relief. The area near my elbow is clearing as long as I keep taking the Benedryl.
Had booster vaccine on 1/12. On 2/8/21 had a positive COVID test.
12/29/21  pt confirmed covid positive this morning after using quick view at home otc covid 19 test. Pt symtoms:  Cough, runny nose, chills X 3 days.
Chest tightness; Warm flushing feeling; This spontaneous case was retrieved on 04-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1679395-1), reported by other health professional and concerned a 71-year-old, male patient.   The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD). The patient's concomitant medications included Tagamet (cimetidine), latanoprost, Dyazide (hydrochlorothiazide, triamterene), Dorzolamide (dorzolamide hydrochloride), Ventolin (salbutamol sulfate) and Wixela Inhub (fluticasone propionate, salmeterol), all used for an unreported indication.   On 07-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; anatomical location: left arm, route of administration: intramuscular, dose and indication: not reported). The batch number reported was 312841.  On the same day, within a few minutes after receiving Fluad Quadrivalent, the patient experienced warm flushing feeling and chest tightness. The 911 was called and the patient was offered to use Benadryl (diphenhydramine) or Epipen (epinephrine), however, the patient refused it. The paramedics arrived shortly after and the patient stated he was starting to feel better. Paramedics assessed him, and his vitals were stable, and lungs were clear. The patient was asked by paramedics if he wanted to go to the hospital to be checked out, but he declined stating he felt like he was back to normal.  On the same day, the patient recovered from the events.   The reporter did not provide causality assessment. The patient's wife thought that he was having a reaction, and the patient was not sure if it was the shot or the oxygen tank causing the problem since the patient was taking oxygen for his COPD.   The case was assessed as non-serious.  Company comment: A 71-year-old, male patient developed hot flushes and chest tightness within a few minutes after vaccination with the suspect product Fluad Quadrivalent. Paramedics assessed the patient, and his vitals were stable, and lungs were clear. Based on suggestive time relationship, causality for the reported events is assessed as possibly related.; Reporter's Comments: Within a few minutes, patient's wife came back to pharmacy to tell us she thought he was having a reaction. He hadn't made it far from the pharmacy. He currently uses oxygen for COPD, and he wasn't sure if it was the shot or the oxygen tank causing the problem.; Sender's Comments: A 71-year-old, male patient developed hot flushes and chest tightness within a few minutes after vaccination with the suspect product Fluad Quadrivalent. Paramedics assessed the patient, and his vitals were stable, and lungs were clear. Based on suggestive time relationship, causality for the reported events is assessed as possibly related.
Came down with shingles; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  The case was reported by patient herself. The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication.  After receiving dose of Shingrix, the patient came down with shingles.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication was provided.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.    It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
4 hours after immunizations he began to scream and was inconsolable for 3 hours.